Opioid Free Anaesthesia Versus Opioid Based Anesthesia for Laparscopic Cholecystectomy

NCT06231992 | Unknown DMC

• 1 other identifier: Anesthesia for cholecystectomy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the efficacy of Opioid-free anesthesia (OFA) with opioid anaesthesia (OA) in patients undergoing laparoscopic cholecystectomy (LC).

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Visual analogue score

  assessment of postopeative pain after laparoscopic cholecystectomy Score ranging from 0 to 10. 0 = the best , 10= the worst

  first postoperative day after surgery

Study Arms (2)

opioid based anesthesia

ACTIVE COMPARATOR

I.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg). Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline.

Procedure: opioid anaesthesia

opioid free anesthesia

ACTIVE COMPARATOR

\- IV Ketamine (0.25-0.5 mg/kg) before induction of general anesthesia with I.V propofol (1-2 mg/kg), atracurium (0.5mg/kg) followed by(0.25mg /min) infusion of ketamine for maintenance. Dexamethasone I.V (8 mg) will be given before induction of general anesthesia. magnesium sulphate (20 mg/kg)in 100ml saline within 10 mints Followed by infusion of magnesium sulphate at rate of (10mg/kg/h).

Procedure: Opioid free anaesthesia

Interventions

opioid anaesthesia PROCEDURE

I.V Fentanyl (1-2ug/kg) before induction of general anesthesia with I.V propofol (1-2mg/kg), atracurium (0.5mg/kg). Intermittent boluses of fentanyl will be given intraoperatively when needed to maintain the change in hemodynamics within 20 % of the baseline.

opioid based anesthesia

Opioid free anaesthesia PROCEDURE

* IV Ketamine (0.25-0.5 mg/kg) before induction of general anesthesia with I.V propofol (1-2 mg/kg), atracurium (0.5mg/kg) followed by(0.25mg /min) infusion of ketamine for maintenance * Dexamethasone I.V (8 mg) will be given before induction of general anesthesia. * magnesium sulphate (20 mg/kg)in 100ml saline within 10 mints Followed by infusion of magnesium sulphate at rate of (10mg/kg/h).

opioid free anesthesia

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• scheduled for laparoscopic cholecystectomy
• american society of anaesthesiologists' physical status ǀ and ǁ
• body mass index less than 30

You may not qualify if:

• Patients with uncontrolled hypertension and Diabetes mellitus.
• Patient's currently taking opioid for chronic pain.
• Patients with allergies to study medication.
• Patients with cardiorespiratory disorder.
• Patients with hepatic and renal insufficiency

Sponsors & Collaborators

• Al-Azhar University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 30, 2024
• Study Start: January 31, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share