Brain Neoplasm
Conditions
Keywords
supratentorial craniotomy, extubation response, emergence, tramadol
Brief summary
Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care. The advantages of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelet makes it a safe medication to use for neurosurgical patients after craniotomy. The primary objective of the study is to observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic response (measurement of B.P and H.R) during extubation.
Detailed description
Extubation after intracranial tumor surgery is desirable in order to make an early diagnosis of intracranial complications. Extubation however, may be associated with haemodynamic and metabolic changes e.g. agitation, increased oxygen consumption, catecholamine secretion, hypercapnia and systemic hypertension. These changes cause cerebral hyperemia, intracranial hypertension leading to cerebral oedema or haemorrhage, thus it is important to have smooth extubation with minimal haemodynamic and metabolic effects. Incidence of coughing on emergence from general anesthesia ranges from 38% to 96%. This may also result in postoperative intracranial hemorrhage, intracranial hypertension, cerebral edema or intraocular hypertension.This can be detrimental in neurosurgery. Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care. Tramadol, a synthetic opioid of the aminocyclohexanes group, is a centrally acting opioid analgesic that is used to treat moderate-to-severe pain and has an inhibitory effect on M1 and M3 muscarinic receptors. It also reduces the incidence of cough and improves extubation quality, and provides more stable haemodynamics during emergence. It neither causes respiratory depression, nor affects intracranial pressure (ICP) and cerebral perfusion pressure (CPP). Other potential advantage of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelets thus making it a safe medication to use for neurosurgical patients after craniotomy. The onset of effect following a single dose is 3 to 5 minutes with peak effect at 45 minutes. Aim of doing this study is to observe the effect of a single dose of tramadol on quality of tracheal extubation as judged by incidence of coughing and haemodynamic changes at emergence from anesthesia. OBJECTIVE: Primary Objective: To observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on haemodynamic response (measurement of B.P and H.R) during extubation. Secondary Objective: To measure the quality of emergence from general anaesthesia by measuring the frequency of cough, laryngospasm and episodes of desaturation. OPERATIONAL DEFINITION: Emergence Period: This will be defined as the time from the recovery of spontaneous breathing after giving reversal to tracheal extubation. Quality of emergence: Good quality emergence will be defined as extubation not associated with coughing, bucking, tachycardia, hypertension, laryngospasm or bronchospasm. Tachycardia and hypertension: Rise in heart rate and blood pressure more than 20% from baseline value. Extubation response: Physiological response related to blood pressure and heart rate during extubation of trachea is called extubation response, HYPOTHESIS: Tramadol obtunds haemodynamic and cough response to extubation and thus results in good quality emergence after supratentorial craniotomy.
Interventions
DRUGInjection Tramadol
OTHERplacebo
0.9% Normal saline in 10 ml syringe
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with craniotomy for supratentorial tumors under general anesthesia * American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients * Elective surgery * Patients with Glasgow Coma Scale (GCS) 15/15
Exclusion criteria
* Patients with a history of allergy or hypersensitivity to tramadol. * History of epilepsy or convulsions due to any reason. * Chronic usage of analgesic drugs. * Patients using monoamine oxidase inhibitors. * Patients with clinical signs of raised ICP. * Obesity (women with a body mass index \>35 kg/m2 or men with a body mass index \>42 kg/m2) * Language barrier. * Patients taking B-blockers or Ca channel blockers. * Patients above 65 years of age ( Physiology difference)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemodynamic Parameters at the Time of Emergence and Postextubation | Systolic BP from the time of extubation till 6 hours post operatively | Systolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm. | at the time of extubation till 6 hours postoperatively | If there is any episode of bronchospasm or laryngospasm, it will be noted if it occured during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence |
| Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score | at the time of extubation till 6 hours postoperatively | If there is any episode of sedation it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence. sedation score will be used as 0= no sedation, 1= mildly sedated (eye opening on verbal commands), 2= moderately sedated ( awakens on giving pain), 3= deeply sedated ( not waking up even on pain) |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | at Recovery Room , 2, 4 and 6 hours postoperatively | Post operative nausea vomiting will be recorded at RR, 2, 4 and 6 hours postoperatively. If there is any episode of PONV it will be noted. Absence of it will be considered as smooth emergence |
| Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Cough at the time of emergence | Cough will be described on following scale 5 = No coughing or straining, 4 = Very smooth minimal coughing, 3 = Moderate coughing, 2 = Marked coughing or straining, 1 = Poor extubation Cough will be recorded on the above mentioned scale by resident/consultant at following time intervals of emergence * At resumption of spontaneous breathing, * Ability to respond to verbal commands * At cuff deflation * At extubation * 2 minutes after extubation. It will be noted if it occurs during emergence at the above mentioned time intervals. Absence of it will be considered as smooth emergence. |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | at Recovery Room, 2, 4 and 6 hours postoperatively | Post operative Glasgow Coma Scale (GCS) will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively. If there is any deterioration in GCS less than 8/15, Patients will be intubated. GCS categories \<8 Low GCS 9-12 Intermediate GCS 13-15 Full GCS |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | At Recovery room, 2, 4 and 6 hours postoperatively | Requirement of analgesia will be recorded at recovery room, 2, 4 and 6 hours postoperatively. If there is any need of analgesic, it will be noted and will be considered as one of the determinants of poor quality of emergence. |
| Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at the time of extubation | If there is any episodes of denaturation (Oxygen saturation \<92%), it will be noted it it is occurring during emergence. Absence of it will be considered as smooth emergence |
| Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | at Recovery Room, 2, 4 and 6 hours postoperatively | Convulsions will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively.If there is any episode of convulsion, it will be noted. Absence of it will be considered as smooth emergence. |
Countries
Pakistan
Participant flow
Recruitment details
Over a period of two years, 2016 and 2017 Patients were recruited in the study during the preoperative anesthesia evaluation either at the preoperative clinic or from the ward after admission.
Pre-assignment details
A total of 80 patients were enrolled and selected to randomize. 39 patients in Tramadol group and 41 patients in placebo group.79 patients completed the study as one patient in tramadol group dropped out due to change/ modification in his surgical procedure.
Participants by arm
| Arm | Count |
|---|---|
| Tramadol Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure | 38 |
| Placebo 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure | 41 |
| Total | 79 |
Baseline characteristics
| Characteristic | Tramadol | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 43.42 Years STANDARD_DEVIATION 13.2 | 45.9 Years STANDARD_DEVIATION 15.9 | 44.7 Years STANDARD_DEVIATION 14.6 |
| BMI | 26.2 kg/m2 STANDARD_DEVIATION 4.8 | 27.1 kg/m2 STANDARD_DEVIATION 4.88 | 26.7 kg/m2 STANDARD_DEVIATION 4.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 38 Participants | 41 Participants | 79 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 00 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Pakistan | 38 participants | 41 participants | 79 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 27 Participants | 28 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 41 |
| other Total, other adverse events | 0 / 38 | 0 / 41 |
| serious Total, serious adverse events | 0 / 38 | 1 / 41 |
Outcome results
Primary
Haemodynamic Parameters at the Time of Emergence and Postextubation
Systolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.
Time frame: Systolic BP from the time of extubation till 6 hours post operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min Before Extubation | 132.63 mm Hg | Standard Deviation 22.12 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 20min | 127.86 mm Hg | Standard Deviation 14.56 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2 min | 134.89 mm Hg | Standard Deviation 21.57 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 30min | 127.19 mm Hg | Standard Deviation 16.29 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | Baseline | 128.55 mm Hg | Standard Deviation 21.56 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1h | 128.11 mm Hg | Standard Deviation 14.47 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 5min | 130.05 mm Hg | Standard Deviation 20.06 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2h | 127.76 mm Hg | Standard Deviation 16.21 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min After Extubation | 141.81 mm Hg | Standard Deviation 23.15 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 4h | 127.35 mm Hg | Standard Deviation 15.48 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 10min | 126.95 mm Hg | Standard Deviation 17.26 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 6h | 122.97 mm Hg | Standard Deviation 14.18 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 6h | 122.61 mm Hg | Standard Deviation 17.79 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | Baseline | 132.34 mm Hg | Standard Deviation 22.38 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min Before Extubation | 134.29 mm Hg | Standard Deviation 24.4 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min After Extubation | 143.70 mm Hg | Standard Deviation 22.97 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2 min | 139.77 mm Hg | Standard Deviation 22.28 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 5min | 133.37 mm Hg | Standard Deviation 21.08 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 10min | 131.59 mm Hg | Standard Deviation 17.35 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 20min | 133.15 mm Hg | Standard Deviation 15.68 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 30min | 132.10 mm Hg | Standard Deviation 17.05 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1h | 129.80 mm Hg | Standard Deviation 16.51 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2h | 125.74 mm Hg | Standard Deviation 13.3 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 4h | 125.81 mm Hg | Standard Deviation 12.58 |
Primary
Haemodynamic Parameters at the Time of Emergence and Postextubation
Heart rate will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If haemodynamic values of heart rate rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.
Time frame: HR from the time of extubation till 6 hours post operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 5min | 86.27 bpm | Standard Deviation 15.77 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 30min | 81.92 bpm | Standard Deviation 14.19 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 10min | 86.26 bpm | Standard Deviation 16.59 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 20min | 82.44 bpm | Standard Deviation 16.18 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1h | 79.53 bpm | Standard Deviation 13.34 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2h | 80.03 bpm | Standard Deviation 13.4 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 4h | 78.94 bpm | Standard Deviation 13.2 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 6h | 79.65 bpm | Standard Deviation 11.78 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | Baseline | 82.26 bpm | Standard Deviation 12.77 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min Before Extubation | 89.30 bpm | Standard Deviation 14.5 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min After Extubation | 93.61 bpm | Standard Deviation 15.39 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2 min | 89.61 bpm | Standard Deviation 16.71 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min After Extubation | 98.54 bpm | Standard Deviation 19.81 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 4h | 81.23 bpm | Standard Deviation 16.58 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 5min | 90.00 bpm | Standard Deviation 17.4 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min Before Extubation | 91.41 bpm | Standard Deviation 16.96 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 10min | 86.70 bpm | Standard Deviation 16.76 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 6h | 78.20 bpm | Standard Deviation 15.94 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 20min | 83.38 bpm | Standard Deviation 15.2 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 30min | 84.10 bpm | Standard Deviation 14.95 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2 min | 93.50 bpm | Standard Deviation 17.46 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1h | 82.46 bpm | Standard Deviation 13.52 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | Baseline | 79.37 bpm | Standard Deviation 16.93 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2h | 81.97 bpm | Standard Deviation 14.9 |
Primary
Haemodynamic Parameters at the Time of Emergence and Postextubation
Diastolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.
Time frame: Diastolic BP from the time of extubation till 6 hours post operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min Before Extubation | 77.30 mm Hg | Standard Deviation 11.96 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 20min | 78.19 mm Hg | Standard Deviation 9.54 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2 min | 79.19 mm Hg | Standard Deviation 10.79 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 30min | 77.14 mm Hg | Standard Deviation 9.67 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | Base line | 75.92 mm Hg | Standard Deviation 11.48 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1h | 76.39 mm Hg | Standard Deviation 8.9 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 5min | 78.68 mm Hg | Standard Deviation 10.63 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2h | 75.71 mm Hg | Standard Deviation 11.07 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min After Extubation | 83.97 mm Hg | Standard Deviation 10.69 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 4h | 74.85 mm Hg | Standard Deviation 9.96 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 10min | 77.37 mm Hg | Standard Deviation 10.26 |
| Tramadol | Haemodynamic Parameters at the Time of Emergence and Postextubation | 6h | 75.26 mm Hg | Standard Deviation 12.54 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 10min | 78.32 mm Hg | Standard Deviation 8.43 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | Base line | 77.83 mm Hg | Standard Deviation 12.93 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min Before Extubation | 78.65 mm Hg | Standard Deviation 12.63 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1min After Extubation | 85.78 mm Hg | Standard Deviation 13.59 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2 min | 82.41 mm Hg | Standard Deviation 12.32 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 5min | 78.59 mm Hg | Standard Deviation 10.09 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 6h | 74.89 mm Hg | Standard Deviation 11.72 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 20min | 76.73 mm Hg | Standard Deviation 9.77 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 30min | 76.93 mm Hg | Standard Deviation 9.37 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 1h | 75.33 mm Hg | Standard Deviation 8.64 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 2h | 75.89 mm Hg | Standard Deviation 8.87 |
| Placebo | Haemodynamic Parameters at the Time of Emergence and Postextubation | 4h | 78.00 mm Hg | Standard Deviation 11.96 |
Secondary
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia
Requirement of analgesia will be recorded at recovery room, 2, 4 and 6 hours postoperatively. If there is any need of analgesic, it will be noted and will be considered as one of the determinants of poor quality of emergence.
Time frame: At Recovery room, 2, 4 and 6 hours postoperatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | Recovery Room | 5 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | 2h | 15 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | 4h | 3 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | 6h | 6 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | 6h | 7 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | Recovery Room | 3 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | 4h | 4 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia | 2h | 23 Participants |
Secondary
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions
Convulsions will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively.If there is any episode of convulsion, it will be noted. Absence of it will be considered as smooth emergence.
Time frame: at Recovery Room, 2, 4 and 6 hours postoperatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | Recovery Room | 0 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | 2h | 0 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | 4h | 1 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | 6h | 0 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | 6h | 0 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | Recovery Room | 0 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | 4h | 0 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions | 2h | 0 Participants |
Secondary
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS
Post operative Glasgow Coma Scale (GCS) will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively. If there is any deterioration in GCS less than 8/15, Patients will be intubated. GCS categories \<8 Low GCS 9-12 Intermediate GCS 13-15 Full GCS
Time frame: at Recovery Room, 2, 4 and 6 hours postoperatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Recovery Room : <8 | 0 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Recovery Room : 9-12 | 1 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Recovery Room : 13-15 | 38 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 2h : <8 | 0 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 2h : 9-12 | 1 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 2h : 13-15 | 38 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 4h : <8 | 0 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 4h : 9-12 | 0 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 4h : 13-15 | 39 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 6h : <8 | 0 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 6h : 9-12 | 0 Number of Patients |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 6h : 13-15 | 39 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 6h : 9-12 | 0 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Recovery Room : <8 | 0 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 4h : <8 | 1 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Recovery Room : 9-12 | 0 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 6h : <8 | 1 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | Recovery Room : 13-15 | 41 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 4h : 9-12 | 0 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 2h : <8 | 0 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 6h : 13-15 | 40 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 2h : 9-12 | 1 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 4h : 13-15 | 40 Number of Patients |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS | 2h : 13-15 | 40 Number of Patients |
Secondary
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV
Post operative nausea vomiting will be recorded at RR, 2, 4 and 6 hours postoperatively. If there is any episode of PONV it will be noted. Absence of it will be considered as smooth emergence
Time frame: at Recovery Room , 2, 4 and 6 hours postoperatively
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | Recovery Room | 0 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | 2h | 3 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | 4h | 0 Participants |
| Tramadol | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | 6h | 0 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | 6h | 1 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | Recovery Room | 0 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | 4h | 1 Participants |
| Placebo | Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV | 2h | 3 Participants |
Secondary
Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score
If there is any episode of sedation it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence. sedation score will be used as 0= no sedation, 1= mildly sedated (eye opening on verbal commands), 2= moderately sedated ( awakens on giving pain), 3= deeply sedated ( not waking up even on pain)
Time frame: at the time of extubation till 6 hours postoperatively
Population: The data was inconsistent and was not reported adequately in the questionnaire.
Secondary
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.
Cough will be described on following scale 5 = No coughing or straining, 4 = Very smooth minimal coughing, 3 = Moderate coughing, 2 = Marked coughing or straining, 1 = Poor extubation Cough will be recorded on the above mentioned scale by resident/consultant at following time intervals of emergence * At resumption of spontaneous breathing, * Ability to respond to verbal commands * At cuff deflation * At extubation * 2 minutes after extubation. It will be noted if it occurs during emergence at the above mentioned time intervals. Absence of it will be considered as smooth emergence.
Time frame: Cough at the time of emergence
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Moderate coughing | 1 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Very smooth minimal coughing | 1 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Moderate coughing | 1 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | No coughing or straining | 34 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | No coughing or straining | 33 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Poor extubation | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Very smooth minimal coughing | 3 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Marked coughing or straining | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Marked coughing or straining | 2 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Moderate coughing | 2 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | No coughing or straining | 34 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Very smooth minimal coughing | 4 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Poor extubation | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | No coughing or straining | 32 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Poor extubation | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Poor extubation | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Very smooth minimal coughing | 2 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Marked coughing or straining | 2 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Marked coughing or straining | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Moderate coughing | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Marked coughing or straining | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Very smooth minimal coughing | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Moderate coughing | 3 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | No coughing or straining | 36 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Poor extubation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | No coughing or straining | 37 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Poor extubation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Marked coughing or straining | 2 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Moderate coughing | 1 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | Very smooth minimal coughing | 2 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At resumption of spontaneous breathing | No coughing or straining | 36 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Poor extubation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Marked coughing or straining | 1 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Moderate coughing | 1 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | Very smooth minimal coughing | 2 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | Ability to respond to verbal commands | No coughing or straining | 37 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Poor extubation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Marked coughing or straining | 1 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Moderate coughing | 3 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | Very smooth minimal coughing | 4 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At cuff deflation | No coughing or straining | 33 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Poor extubation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Marked coughing or straining | 1 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Moderate coughing | 2 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | Very smooth minimal coughing | 6 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | At extubation | No coughing or straining | 32 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Poor extubation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Marked coughing or straining | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Moderate coughing | 2 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale. | 2 minutes after extubation | Very smooth minimal coughing | 2 Participants |
Secondary
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation
If there is any episodes of denaturation (Oxygen saturation \<92%), it will be noted it it is occurring during emergence. Absence of it will be considered as smooth emergence
Time frame: at the time of extubation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at the time of obeying of verbal commands | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at the time of extubation | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at the time of cuff deflation | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | 2 min after extubation | 0 Participants |
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at resumption of spontaneous breathing | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | 2 min after extubation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at resumption of spontaneous breathing | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at the time of obeying of verbal commands | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at the time of cuff deflation | 0 Participants |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation | at the time of extubation | 0 Participants |
Secondary
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.
If there is any episode of bronchospasm or laryngospasm, it will be noted if it occured during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence
Time frame: at the time of extubation till 6 hours postoperatively
Population: Laryngospasm and Bronchospasm and breath holding did not occur, therefore not shown there.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tramadol | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm. | 0 Number of Patients |
| Placebo | Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm. | 0 Number of Patients |