Quality of Recovery After Laparoscopic Cholecystectomy Comparing Opioid Free Analgesia Versus Opioid Free Anesthesia

NCT06343753 | Completed

• 1 other identifier: FMASU MD46/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the quality of recovery from general anesthesia and surgery using the quality of recovery 15 item scale (QoR-15) for participant's receiving opioid-Sparing anesthesia with those receiving standard opioid-containing anesthesia in Patients undergoing a scheduled laparoscopic cholecystectomy.

Conditions

Quality of Recovery; Pain, Postoperative; Elective Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  The 15-item quality of recovery (QoR-15) score at 24 h postoperatively. o The QoR-15 score : is a shorter validated version of the QoR-40 and provides an efficient evaluation of post-operative recovery from the participant's perspective with total QoR-15 score ranging from 0 (extremely poor recovery) to 150 (excellent recovery).(Stark et al.,2013) Each question is measured on a Likert scale ranging from 0-10; where 0 = none of the time \[poor\] to 10 = all of the time \[excellent\]. Results are considered clinically significant if there is a change of score of eight.

  24 hour

Secondary Outcomes (6)

• Post operative pain

  24 hour

• Postoperative Hypoxia

  24 hour

• Postoperative nausea and vomiting

  24 hour

• Postoperative bradycardia

  24 hour

• Postoperative hypotension

  24 hour

Study Arms (2)

Opioid free anesthesia (OFA) group

ACTIVE COMPARATOR

Analgesia will be provided by syringe containing ketamine, Lidocaine and Dexmedetomidine in induction and maintenance according to lean body weight (LBW). Induction : Ketamine: 0.5 mg/kg (IBW), Lidocaine 1 mg/kg and dexmedetomidine 0.5 mg/kg (LBW) for induction to be given in 10 ml syringe over 10 minutes. Maintenance : The maintenance mixture" - 50 cc syringe containing: 50 mcg Dexmedetomidine (0.5 cc of standard 100 mcg/ml solution) 50 mg Ketamine 500 mg Lidocaine (25 ml of standard 2% solution) NaCl up to total 50 ml

Drug: Opioid free analgesia

Opioid based anesthesia( OBA )group

ACTIVE COMPARATOR

Fentanyl 2 g/kg (LBW) as induction dose in 10 ml syringe to be given over 10 minutes, and 1 g/kg/h in 50 ml syringe as infusion during operation starting before skin incision for Group TBA.

Drug: Opioid based Anesthesia

Interventions

Opioid free analgesia DRUG

o Group OFA: Opioid free anesthesia Analgesia will be provided by syringe containing ketamine, Lidocaine and Dexmedetomidine in induction and maintenance according to lean body weight (LBW).

Also known as: Dexmedetomidine, Lidocaine, Ketamine, Bupivacaine, Ondansetron, Metoclopramide, Propofol

Opioid free anesthesia (OFA) group

Opioid based Anesthesia DRUG

o Group TBA: Traditional balanced anesthesia Analgesia will be provided by fentanyl in induction and maintenance according to Ideal Body Weight (IBW)

Also known as: Fentanyl, Propofol, Ondansetron, Metoclopramide, Bupivacaine

Opioid based anesthesia( OBA )group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group: 18-65 year of both sex.
• Patients with ASA (American society of anesthesiologist) classification I-II.
• Undergoing a scheduled laparoscopic cholecystectomy

You may not qualify if:

• Pregnant or breast-feeding women
• ASA physical status class \> 2
• The need to change laparoscopic surgery to an open one
• Allergy to any of the drugs used in the study
• local skin infection at the trocar injection site
• st or 2nd degree Heart block
• Chronic treatment by beta-blockers
• HR \<50 bpm
• Epilepsy or seizures
• Alcohol or drug abuse
• Psychiatric disease
• History of chronic pain

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Lidocaine; Ketamine; Bupivacaine; Ondansetron; Metoclopramide; Propofol; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Phenyl Ethers; Phenols; Piperidines

Study Design

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

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 3, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 20, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)