Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries

Early Phase 1Enrolling By InvitationNCT06561672

Zagazig University102 enrolled

Overview

Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl

Interventions

tramadol plus paracetamolDRUG

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)

FentanylDRUG

Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient followed by induction agents (propofol 2mg/kg).

propofol and muscle relaxant (cisatracurium)DRUG

propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Aculty of Medicine,Zagazig University

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

Enhanced recovery score

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.

Time frame: at the end of 24 hour after surgery.

Secondary Outcomes

The duration of PACU stay

time from patient admission to the PACU till discharge from the PACU

Time frame: 2 days postoperative

Duration of postoperative hospital stay

time from patient admission to the PACU till the hospital discharge admission to the PACU till the hospital discharge

Time frame: 2 days postoperative

Postoperative pain severity

(a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border).

Time frame: recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based

postoperative agitation score

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

Data from ClinicalTrials.gov

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