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

NCT ID: NCT06561672

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-20

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.

Conditions

Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tramadol plus paracetamol (T)

Group Type: EXPERIMENTAL

tramadol plus paracetamol

Intervention Type: DRUG

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)

propofol and muscle relaxant (cisatracurium)

Intervention Type: DRUG

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

fentanyl(F)

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

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

Propofol

Intervention Type: DRUG

propofol 2mg/kg

Interventions

tramadol plus paracetamol

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)

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

propofol and muscle relaxant (cisatracurium)

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

Intervention Type: DRUG

Propofol

propofol 2mg/kg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mohamed Medhat

assistant professor of anesthesia and surgical intensive care(Principal Investigator)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

marwa M Medhat, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Aculty of Medicine,Zagazig University

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

459

Identifier Type: -

Identifier Source: org_study_id