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Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery

Preoperative Gabapentin Versus Bisoprolol for Intraoperative Hemodynamic and Surgical Field Optimization During Endoscopic Sinus Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03850093
Enrollment
63
Registered
2019-02-21
Start date
2015-08-31
Completion date
2016-12-31
Last updated
2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

gabapentin, bisoprolol, hemodynamic, surgical field

Brief summary

the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate . A prospective randomized double blinded controlled study. Eligible patients were randomized according to random list generated software and allocated into 3 equal and matched groups (15 patients in each group):- * Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200 mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of anesthesia. * Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5 mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of anesthesia. * Group C: control group in which Patients were premedicated with oral placebo with sips of water, 2 hours before induction of anesthesia.

Detailed description

Hypothesis: Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate. Objectives Compare the effect of preoperative Gabapentin with Bisoprolol on hemodynamics, surgical field optimization during endoscopic nasal surgeries. Technical design: A) Site of study : The study was conducted at Anesthesia and Surgical intensive care and Otorhinolaryngology departments, faculty of medicine, Zagazig University. B) Sample Size : According to 80% power of the study, 95% CI and calculated volume of blood loss 200±40 ml and 150±55ml on Gabapentin (22) and Bisoprolol (15) premedication respectively, the estimated Sample size was 54 patients (open EPI) , 63 patients were included in the study to compensate for drop out. Randomization was carried out on 63 patients to compensate for drop out . All planned ESS procedures was managed by the same anesthetist and surgeon who were blinded to the used study's premedication. The surgeon was blinded to the monitor recording the hemodynamic variables. All patients had been preoperatively evaluated according to standard local protocol. Preoperative surgical preparation and proper management of infection were confirmed to every patient. Patient was premedicated by IV ranitidine 50 mg, midazolam 0.05 mg/kg and atropine 20µg/kg immediately before admission to the operating room. On admission to the operating room, Standard monitoring included 5 leads ECG, non-invasive blood pressure, Pulse Oximetry and End-tidal carbon dioxide (ETCO2) trace were applied (B40i Monitor - GE Healthcare, Finland). Anesthesia was induced with IV propofol 2 mg/kg and fentanyl 1 µg/kg was given for analgesia. Cisatracurium 0.15 mg/kg IV was given to facilitate direct laryngoscopy and orotracheal intubation. The patient was ventilated at tidal volume 6-8mL/kg and respiratory rate that achieved ETCO2 of 30-35 mmHg. Oropharyngeal pack was inserted. Anesthesia was maintained by isoflurane based on MAC 1.2 % until a steady state of anesthesia was achieved (defined as a state of anesthesia when no changes in hemodynamic variables take place for at least 10 min). An increase of ≥ 20% of basal value in both HR and MAP was treated with increasing the concentration of isoflurane by 0.5% and increments of fentanyl 1 μg/kg. Muscle relaxation was confirmed by cisatracurium 0.03mg/kg every 20 mins. IV lactated ringer solution was infused at approximately 6ml/kg/hr till the end of the procedure. All patients were positioned supine and the bed-head of the surgical table was raised by 30° to improve venous drainage. Before the beginning of surgical procedure, well wrung out cotton pledgets soaked with 4 ml of 2% lignocaine with 1:200,000 adrenaline were topically applied to the nasal mucous membrane for 10 min (no infiltration). Technique for hemodynamic optimization: Target mean arterial pressure (MAP) was 60-70 mmHg during the surgical procedure to achieve Fromm and Boezaart category scale of 2 or 3 which is judged to be optimal for surgery (20). If the MAP was still ˃70mmHg in spite of increasing isoflurane inhalation to 2.5%, nitroglycerine (1-10 μg/kg/min.) titrated to effect. If the heart rate was more than 100 beats/ minute, propranolol was titrated 1-3 mg/hour to achieve target MAP. If mean arterial pressure (MAP) decreased to less than 60 mm Hg, ephedrine in increments of 3 mg was given. Withdrawal vasoactive agents: After recording the surgeons' opinion regarding the surgical field and about 15 minutes before ending surgery, the infusion of any vasoactive medication (if used) was stopped and the anesthetic agent was decreased allowing HR and MAP to return to their basal value. If Hypotension (defined as SAP\< 90mmHg and bradycardia less than 60 bpm) persisted, they was treated by ephedrine in increments of 3 mg . On compilation of surgical procedure, anesthesia was discontinued and reversal of neuromuscular blockade was achieved using IV neostigmine 0.08 mg/kg and atropine 20µg/kg. After removal of oropharyngeal pack, oropharyngeal suction was performed. On the start of obeying commands, patients were extubated and shifted to recovery room. Patients were discharged to the ward after reaching a score ≥ 9 on the Modified Aldrete Scoring System. During postoperative period up to 6 hours, the patient was monitored for conscious level, oxygen saturation, heart rate and mean arterial blood pressure. On ward admission, IM diclofenac sodium 75mg was given then every 12 hours. If the patient complained moderate to severe pain (VAS≥ 4) meperidine 25mg increments up to pain relief (maximum 100mg as a single dose) was given.

Interventions

DRUGGabapentin1200 mg

patients received 1200mg gabapentin 2 hrs preoperative

DRUGbisoprolol 2.5mg

patients received 2.5mg bisoprolol 2 hrs preoperative

DRUGplacebo

patients received oral placebo 2 hrs preoperative

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* patients who underwent functional endoscopic sinus surgery * ability to swallow tablets

Exclusion criteria

* suspected difficult airway * basal HR \<60/min. * chronic cardiovascular or cerebrovascular disease * bronchial asthma or COPD * DM * bleeding disorders * anemia (Hb level\< 10 gm/dl) * renal or hepatic insufficiency * psychiatric disorders * chronic treatment by BBs, gabapentin or drugs that affect coagulation * acute nasal infection * allergy/contraindications to any of the study's drugs.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Surgical Field Visibilityscale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the endaccording to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding. 1. Slight bleeding- no blood suctioning required. 2. Slight bleeding- occasional blood suctioning required. 3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation. 4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation. 5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.
Blood Lossat the end of surgerytotal intraoperative blood loss (mL)

Secondary

MeasureTime frameDescription
Heart Rate Changewere recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgeryeffect of intervention on the change of heart rate allover study period
Mean Arterial Blood Pressure Changewere recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgeryeffect of intervention on the change of mean arterial blood pressure allover study period

Other

MeasureTime frameDescription
Visual Analogue Scale (VAS) for Postoperative Pain1, 3 and 6 hrs. after recoverypostoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed
Surgeon Satisfaction (Categorical)at the end of surgerysurgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups
Time to 1st Postoperative Rescue Analgesiaon administration of 1st postoperative rescue analgesiatime to 1st postoperative rescue analgesia (starting from administration of the studied drug)
Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedureat the end of surgeryneed for additional intraoperative IV vasodilators (nitroglycerine
Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedureat the end of surgerythe need for additional beta blockers (propranolol)
Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedureat the end of surgeryneed for both IV nitroglycerine and propranolol intraoperatively

Participant flow

Recruitment details

66 patients who underwent endoscopic sinus surgery were eligible for the study

Participants by arm

ArmCount
Gabapentin
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
21
Bisoprolol
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
22
Control
placebo was given to patients of control group 2 hours preoperative
17
Total60

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyWithdrawal by Subject102

Baseline characteristics

CharacteristicTotalBisoprololGabapentinControl
Age, Continuous27.93 years
STANDARD_DEVIATION 6.97
30.5 years
STANDARD_DEVIATION 6.6
27.1 years
STANDARD_DEVIATION 7.6
28.6 years
STANDARD_DEVIATION 5.1
heart rate (HR), continuous86.7 beats/minute
STANDARD_DEVIATION 11.98
82.9 beats/minute
STANDARD_DEVIATION 6.4
91.1 beats/minute
STANDARD_DEVIATION 11.6
83.8 beats/minute
STANDARD_DEVIATION 14.8
indication for surgery, categorical)
polyp
34 Participants13 Participants11 Participants10 Participants
indication for surgery, categorical)
sinusitis
26 Participants9 Participants10 Participants7 Participants
mean arterial blood pressure (MAP), continuous93.4 mmHg
STANDARD_DEVIATION 9.7
92.9 mmHg
STANDARD_DEVIATION 7.4
96.6 mmHg
STANDARD_DEVIATION 7.5
88.2 mmHg
STANDARD_DEVIATION 11.7
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
23 Participants9 Participants8 Participants6 Participants
Sex: Female, Male
Male
37 Participants13 Participants13 Participants11 Participants
side of surgery
bilateral
34 Participants11 Participants14 Participants9 Participants
side of surgery
unilateral
26 Participants11 Participants7 Participants8 Participants
weight, continuous85.62 kilograms
STANDARD_DEVIATION 11.5
87.9 kilograms
STANDARD_DEVIATION 11.9
87.1 kilograms
STANDARD_DEVIATION 1.1
84.5 kilograms
STANDARD_DEVIATION 11.5

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 220 / 17
other
Total, other adverse events
0 / 213 / 2210 / 17
serious
Total, serious adverse events
0 / 215 / 2211 / 17

Outcome results

Primary

Blood Loss

total intraoperative blood loss (mL)

Time frame: at the end of surgery

ArmMeasureValue (MEDIAN)
GabapentinBlood Loss20 mL
BisoprololBlood Loss20 mL
ControlBlood Loss80 mL
Primary

Changes in Surgical Field Visibility

according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding. 1. Slight bleeding- no blood suctioning required. 2. Slight bleeding- occasional blood suctioning required. 3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation. 4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation. 5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.

Time frame: scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end

ArmMeasureGroupValue (MEDIAN)
GabapentinChanges in Surgical Field Visibility30 minutes1 score on a scale
GabapentinChanges in Surgical Field Visibility105 minutes1 score on a scale
GabapentinChanges in Surgical Field Visibility60 minutes1 score on a scale
GabapentinChanges in Surgical Field Visibility15 minutes2 score on a scale
GabapentinChanges in Surgical Field Visibility90 minutes1 score on a scale
GabapentinChanges in Surgical Field Visibility75 minutes1 score on a scale
GabapentinChanges in Surgical Field Visibility45 minutes1 score on a scale
BisoprololChanges in Surgical Field Visibility60 minutes1 score on a scale
BisoprololChanges in Surgical Field Visibility15 minutes2 score on a scale
BisoprololChanges in Surgical Field Visibility30 minutes1 score on a scale
BisoprololChanges in Surgical Field Visibility45 minutes1 score on a scale
BisoprololChanges in Surgical Field Visibility75 minutes1 score on a scale
BisoprololChanges in Surgical Field Visibility90 minutes0 score on a scale
BisoprololChanges in Surgical Field Visibility105 minutes0 score on a scale
ControlChanges in Surgical Field Visibility30 minutes3 score on a scale
ControlChanges in Surgical Field Visibility90 minutes3 score on a scale
ControlChanges in Surgical Field Visibility15 minutes4 score on a scale
ControlChanges in Surgical Field Visibility105 minutes2 score on a scale
ControlChanges in Surgical Field Visibility60 minutes3 score on a scale
ControlChanges in Surgical Field Visibility75 minutes2 score on a scale
ControlChanges in Surgical Field Visibility45 minutes3 score on a scale
Secondary

Heart Rate Change

effect of intervention on the change of heart rate allover study period

Time frame: were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery

ArmMeasureGroupValue (MEAN)Dispersion
GabapentinHeart Rate Change5 minutes after intubation77.1 beats/ minuteStandard Deviation 10
GabapentinHeart Rate Change75 minutes after intubation75.7 beats/ minuteStandard Deviation 8.9
GabapentinHeart Rate Change30 minutes after intubation73.4 beats/ minuteStandard Deviation 9.4
GabapentinHeart Rate Change10 minutes after intubation75.4 beats/ minuteStandard Deviation 8.6
GabapentinHeart Rate Change60 minutes after intubation75.3 beats/ minuteStandard Deviation 7.4
GabapentinHeart Rate Change15 minutes after intubation74.7 beats/ minuteStandard Deviation 8.8
GabapentinHeart Rate Change105 minutes after intubation75.7 beats/ minuteStandard Deviation 8.1
GabapentinHeart Rate Change1 minute after intubation83.3 beats/ minuteStandard Deviation 11.1
GabapentinHeart Rate Changepreinduction82.6 beats/ minuteStandard Deviation 10.4
GabapentinHeart Rate Change90 minutes after intubation72.7 beats/ minuteStandard Deviation 8.4
GabapentinHeart Rate Change45 minutes after intubation75 beats/ minuteStandard Deviation 7.4
GabapentinHeart Rate Changeafter induction74.9 beats/ minuteStandard Deviation 11.8
BisoprololHeart Rate Changeafter induction67.8 beats/ minuteStandard Deviation 6.8
BisoprololHeart Rate Change1 minute after intubation73.3 beats/ minuteStandard Deviation 9.4
BisoprololHeart Rate Change15 minutes after intubation66.6 beats/ minuteStandard Deviation 5.8
BisoprololHeart Rate Changepreinduction73.1 beats/ minuteStandard Deviation 9.5
BisoprololHeart Rate Change5 minutes after intubation70.6 beats/ minuteStandard Deviation 8.8
BisoprololHeart Rate Change10 minutes after intubation66.3 beats/ minuteStandard Deviation 5.4
BisoprololHeart Rate Change30 minutes after intubation67.7 beats/ minuteStandard Deviation 4.9
BisoprololHeart Rate Change45 minutes after intubation67.1 beats/ minuteStandard Deviation 4.2
BisoprololHeart Rate Change60 minutes after intubation66.3 beats/ minuteStandard Deviation 4.8
BisoprololHeart Rate Change75 minutes after intubation66 beats/ minuteStandard Deviation 4.3
BisoprololHeart Rate Change90 minutes after intubation66.5 beats/ minuteStandard Deviation 3.4
BisoprololHeart Rate Change105 minutes after intubation67.4 beats/ minuteStandard Deviation 5.7
ControlHeart Rate Change75 minutes after intubation84.5 beats/ minuteStandard Deviation 14.1
ControlHeart Rate Change45 minutes after intubation80.1 beats/ minuteStandard Deviation 14.7
ControlHeart Rate Change90 minutes after intubation88.1 beats/ minuteStandard Deviation 14.3
ControlHeart Rate Changeafter induction85.9 beats/ minuteStandard Deviation 16.7
ControlHeart Rate Change60 minutes after intubation87.3 beats/ minuteStandard Deviation 13.5
ControlHeart Rate Change1 minute after intubation96.2 beats/ minuteStandard Deviation 18.8
ControlHeart Rate Change10 minutes after intubation87.8 beats/ minuteStandard Deviation 19.1
ControlHeart Rate Change15 minutes after intubation90.2 beats/ minuteStandard Deviation 19.8
ControlHeart Rate Change5 minutes after intubation89.3 beats/ minuteStandard Deviation 17.5
ControlHeart Rate Change105 minutes after intubation97 beats/ minuteStandard Deviation 13.2
ControlHeart Rate Change30 minutes after intubation85.8 beats/ minuteStandard Deviation 14.3
ControlHeart Rate Changepreinduction85.8 beats/ minuteStandard Deviation 16
Secondary

Mean Arterial Blood Pressure Change

effect of intervention on the change of mean arterial blood pressure allover study period

Time frame: were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery

ArmMeasureGroupValue (MEAN)Dispersion
GabapentinMean Arterial Blood Pressure Change60 minutes after intubation61.9 mm HgStandard Deviation 4.2
GabapentinMean Arterial Blood Pressure Change75 minutes after intubation62.5 mm HgStandard Deviation 4.4
GabapentinMean Arterial Blood Pressure Changepreinduction85.6 mm HgStandard Deviation 6
GabapentinMean Arterial Blood Pressure Change90 minutes after intubation63 mm HgStandard Deviation 3.5
GabapentinMean Arterial Blood Pressure Change5 minutes after intubation70.7 mm HgStandard Deviation 8.4
GabapentinMean Arterial Blood Pressure Change105 minutes after intubation63.1 mm HgStandard Deviation 3
GabapentinMean Arterial Blood Pressure Changeafter induction74.4 mm HgStandard Deviation 6.9
GabapentinMean Arterial Blood Pressure Change10 minutes after intubation66.4 mm HgStandard Deviation 7.1
GabapentinMean Arterial Blood Pressure Change15 minutes after intubation65.4 mm HgStandard Deviation 4.6
GabapentinMean Arterial Blood Pressure Change30 minutes after intubation64.4 mm HgStandard Deviation 4.4
GabapentinMean Arterial Blood Pressure Change1 minute after intubation80.6 mm HgStandard Deviation 7.6
GabapentinMean Arterial Blood Pressure Change45 minutes after intubation63.3 mm HgStandard Deviation 3.4
BisoprololMean Arterial Blood Pressure Changepreinduction86.4 mm HgStandard Deviation 6.6
BisoprololMean Arterial Blood Pressure Change60 minutes after intubation66.7 mm HgStandard Deviation 4.8
BisoprololMean Arterial Blood Pressure Change1 minute after intubation76.2 mm HgStandard Deviation 12.9
BisoprololMean Arterial Blood Pressure Change45 minutes after intubation64.7 mm HgStandard Deviation 6.6
BisoprololMean Arterial Blood Pressure Change75 minutes after intubation69.4 mm HgStandard Deviation 8.4
BisoprololMean Arterial Blood Pressure Change10 minutes after intubation67.7 mm HgStandard Deviation 10.4
BisoprololMean Arterial Blood Pressure Changeafter induction72.3 mm HgStandard Deviation 9.9
BisoprololMean Arterial Blood Pressure Change90 minutes after intubation66.1 mm HgStandard Deviation 4.7
BisoprololMean Arterial Blood Pressure Change30 minutes after intubation66.2 mm HgStandard Deviation 6.8
BisoprololMean Arterial Blood Pressure Change15 minutes after intubation70.2 mm HgStandard Deviation 8.8
BisoprololMean Arterial Blood Pressure Change105 minutes after intubation67.2 mm HgStandard Deviation 7.7
BisoprololMean Arterial Blood Pressure Change5 minutes after intubation67.2 mm HgStandard Deviation 7.8
ControlMean Arterial Blood Pressure Change105 minutes after intubation70 mm HgStandard Deviation 14.8
ControlMean Arterial Blood Pressure Changepreinduction92.4 mm HgStandard Deviation 9.8
ControlMean Arterial Blood Pressure Changeafter induction78.2 mm HgStandard Deviation 9.1
ControlMean Arterial Blood Pressure Change1 minute after intubation92.2 mm HgStandard Deviation 16.1
ControlMean Arterial Blood Pressure Change5 minutes after intubation78.6 mm HgStandard Deviation 11.1
ControlMean Arterial Blood Pressure Change10 minutes after intubation76.5 mm HgStandard Deviation 12.9
ControlMean Arterial Blood Pressure Change15 minutes after intubation74 mm HgStandard Deviation 12.1
ControlMean Arterial Blood Pressure Change30 minutes after intubation66.6 mm HgStandard Deviation 21.7
ControlMean Arterial Blood Pressure Change60 minutes after intubation69.9 mm HgStandard Deviation 11.3
ControlMean Arterial Blood Pressure Change75 minutes after intubation67.7 mm HgStandard Deviation 5.5
ControlMean Arterial Blood Pressure Change90 minutes after intubation62.7 mm HgStandard Deviation 12.8
ControlMean Arterial Blood Pressure Change45 minutes after intubation64.6 mm HgStandard Deviation 14.3
Other Pre-specified

Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure

need for both IV nitroglycerine and propranolol intraoperatively

Time frame: at the end of surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GabapentinNumber of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure0 Participants
BisoprololNumber of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure0 Participants
ControlNumber of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure6 Participants
Other Pre-specified

Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure

need for additional intraoperative IV vasodilators (nitroglycerine

Time frame: at the end of surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GabapentinNumber of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure0 Participants
BisoprololNumber of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure0 Participants
ControlNumber of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure5 Participants
Other Pre-specified

Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure

the need for additional beta blockers (propranolol)

Time frame: at the end of surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GabapentinNumber of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure0 Participants
BisoprololNumber of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure0 Participants
ControlNumber of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure1 Participants
Other Pre-specified

Surgeon Satisfaction (Categorical)

surgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups

Time frame: at the end of surgery

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
GabapentinSurgeon Satisfaction (Categorical)surgeon satisfaction achieved (score≥ 4)21 Participants
GabapentinSurgeon Satisfaction (Categorical)surgeon satisfaction not achieved(score< 4)0 Participants
BisoprololSurgeon Satisfaction (Categorical)surgeon satisfaction achieved (score≥ 4)22 Participants
BisoprololSurgeon Satisfaction (Categorical)surgeon satisfaction not achieved(score< 4)0 Participants
ControlSurgeon Satisfaction (Categorical)surgeon satisfaction achieved (score≥ 4)10 Participants
ControlSurgeon Satisfaction (Categorical)surgeon satisfaction not achieved(score< 4)7 Participants
Other Pre-specified

Time to 1st Postoperative Rescue Analgesia

time to 1st postoperative rescue analgesia (starting from administration of the studied drug)

Time frame: on administration of 1st postoperative rescue analgesia

ArmMeasureValue (MEDIAN)
GabapentinTime to 1st Postoperative Rescue Analgesia60 minutes
BisoprololTime to 1st Postoperative Rescue Analgesia30 minutes
ControlTime to 1st Postoperative Rescue Analgesia20 minutes
Other Pre-specified

Visual Analogue Scale (VAS) for Postoperative Pain

postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed

Time frame: 1, 3 and 6 hrs. after recovery

Other Pre-specified

Visual Analogue Scale (VAS) for Postoperative Pain

postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain

Time frame: 0n full recovery, 3 and 6 hrs. after recovery

ArmMeasureGroupValue (MEDIAN)
GabapentinVisual Analogue Scale (VAS) for Postoperative Pain3hrs. after recovery1 score on a scale
GabapentinVisual Analogue Scale (VAS) for Postoperative Painon full recovery2 score on a scale
GabapentinVisual Analogue Scale (VAS) for Postoperative Pain6hrs after recovery1 score on a scale
BisoprololVisual Analogue Scale (VAS) for Postoperative Pain3hrs. after recovery3 score on a scale
BisoprololVisual Analogue Scale (VAS) for Postoperative Painon full recovery4 score on a scale
BisoprololVisual Analogue Scale (VAS) for Postoperative Pain6hrs after recovery3 score on a scale
ControlVisual Analogue Scale (VAS) for Postoperative Painon full recovery5 score on a scale
ControlVisual Analogue Scale (VAS) for Postoperative Pain6hrs after recovery3 score on a scale
ControlVisual Analogue Scale (VAS) for Postoperative Pain3hrs. after recovery4 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026