Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl
Conditions
Keywords
paracetamol ,tramadol , fentanyl, day case surgeries
Brief summary
Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.
Detailed description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (T group and F group). Using computer generated randomization table; each group consists of 51 patients:Group (T) (n=51): Patients will receive preemptive intravenous infusion of tramadol plus paracetamol . Group (F) (n=51): Patients will receive preemptive intravenous fentanyl.
Interventions
Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anesthesia (induction agent will be propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg)
DRUGFentanyl
Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient followed by induction agents (propofol 2mg/kg).
DRUGpropofol and muscle relaxant (cisatracurium)
propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg)
DRUGPropofol
propofol 2mg/kg
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for day case surgeries. * Patient acceptance to be included into the study. * Both sex. * Patients with ASA physical status I, II. * BMI 25 - 30 kg m-2. * Duration of surgery from 1-2 hours
Exclusion criteria
-Uncooperative patients and patients with psychological problems.- * Patients with liver or renal impairment. * Patients with history of allergy to drug used in the study. * Patients with chronic pain. * Patient on pain therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enhanced recovery score | at the end of 24 hour after surgery. | A 40-item questionnaire that provides a score (QoR-40) that measure quality of recovery after surgery and anesthesia (enhanced recovery) according to five aspects will be recorded at the end of 24 hours after surgery: Emotional state(n=9) physical comfort(n=12) Psychological support (n=7) physical independence(n=5) pain(n=7) \- Each one of the 40 questions gets a score from one to five at which one is the worst response and five is the best response. When the individual score of all questions are added together we get a total score that ranges from 40 to 200. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration of PACU stay | 2 days postoperative | time from patient admission to the PACU till discharge from the PACU |
| Duration of postoperative hospital stay | 2 days postoperative | time from patient admission to the PACU till the hospital discharge admission to the PACU till the hospital discharge |
| Postoperative pain severity | recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based | (a 10-cm line labeled with worst pain imaginable on the right border and no pain on the left border). |
| postoperative agitation score | immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU: | Score Term Description * 4 Combative Overtly combative, violent, immediate danger to staff * 3 Very agitated Pulls or removes tubes (s) or catheter(s); aggressive * 2 Agitated Frequent non-purposeful movement * 1 Restless Anxious, but not aggressive or vigorous 0 Alert and calm * 1 Drowsy Not fully alert but has sustained awakening (eye opening or eye contact) to voice (\< 10 seconds) * 2 Light sedation Briefly awaken with eye contact to voice (\> 10 seconds) * 3 Moderate sedation Movement or eye opening to voice (but no eye contact)-4 Deep sedation No response to voice, but movement or eye opening to physical stimulation * 5 Unarousable No response to voice or physical stimulation |
Countries
Egypt
Outcome results
None listed