Opioid-based Versus Opioid-free Anaesthesia for Laparoscopic Cholecystectomy

NCT06476600 | Completed

• 1 other identifier: 3338
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, parallel-group, double-blinded clinical trial. The study is approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. The participants of the study will be invited once they receive full trial information from the surgeons or the anesthetists during their pre-assessment visits. The study participants will join only for up to one day after the surgery (Post-operative day-1). The intervention consists of administration of dexmedetomidine infusion in opioid free anesthesia (OFA) group versus Nalbuphine IV bolus in opioid-based anesthesia (OA) group, five minutes before induction of anesthesia. For maintenance in OFA group dexmedetomidine infusion is to be continued whereas in OA group Nalbuphine IV bolus doses will be administered. Once the surgery is completed and after extubation and emergence from anesthesia, all the participants will be transferred to PACU from where they will be in turn discharged to the ward once they will fulfil the recovery discharge criteria. A multi-modal analgesia regimen along with a prophylactic antiemetic medication will be prescribed postoperatively to all the patients in the ward according to the standard protocol of the department.

Conditions

Surgical Procedure, Unspecified; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Mean total Quality of recovery (QoR-15) scores.

  The QoR-15 is a validated patient reported outcome measure (PROM), which provides an effective assessment of post-operative recovery. It consists of a total of 15-items, grading each recovery item on a 10 - point numerical Likert scale with total QoR-15 score ranging from 0 (extremely poor recovery) to 150 (excellent recovery)

  At baseline preoperatively

• Mean total Quality of recovery (QoR-15) scores.

  The QoR-15 is a validated patient reported outcome measure (PROM), which provides an effective assessment of post-operative recovery. It consists of a total of 15-items, grading each recovery item on a 10 - point numerical Likert scale with total QoR-15 score ranging from 0 (extremely poor recovery) to 150 (excellent recovery)

  At 24 hours postoperatively

Secondary Outcomes (18)

• Intraoperative haemodynamic stability

  Measured from start to end of anaesthesia

• Intraoperative haemodynamic stability

  Measured from start to end of anaesthesia

• Intraoperative haemodynamic stability

  Measured from start to end of anaesthesia

• Anaesthesia and recovery clinical outcomes

  Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.

• Anaesthesia and recovery clinical outcomes

  Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.

Study Arms (2)

Opioid-based Anaesthesia

ACTIVE COMPARATOR

Drug: Nalbuphine Injection

Opioid-free Anaesthesia

ACTIVE COMPARATOR

Drug: Dexmedetomidine injection

Interventions

Dexmedetomidine injection DRUG

All the eligible patients will undergo general anaesthesia for their elective surgeries (Laparoscopic Cholecystectomies). For the induction and maintenance of anaesthesia the participants will be randomised in a 1:1 ratio to receive either a standard opioid-based anaesthesia (by Nalbuphine) or opioid-free anaesthesia (by Dexmedetomidine) treatment protocols.

Opioid-free Anaesthesia

Nalbuphine Injection DRUG

All the eligible patients will undergo general anaesthesia for their elective surgeries (Laparoscopic Cholecystectomies). For the induction and maintenance of anaesthesia the participants will be randomised in a 1:1 ratio to receive either a standard opioid-based anaesthesia (by Nalbuphine) or opioid-free anaesthesia (by Dexmedetomidine) treatment protocols.

Opioid-based Anaesthesia

Eligibility Criteria

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

You may qualify if:

• Signed informed consent from the participant.
• All patients who are aged between 18 - 65 years.
• American Society of Anaesthesiologists (ASA) classification of I and II
• Elective Laparoscopic cholecystectomies.

You may not qualify if:

• American Society of Anaesthesiologists (ASA) classification of III and above
• Non-elective surgery
• Body Mass Index \> 35
• Patients with regular prescription of Beta-blockers
• Pregnant or breastfeeding women
• Allergy to Opioids and/or other drugs used in the trial.
• Chronic use of opioids or benzodiazepines
• Chronic pain patients
• Patients with cardiovascular, renal, hepatic or central nervous system diseases
• Patients with psychiatric illness

Sponsors & Collaborators

• Atif Shafqat: lead

Study Sites (1)

Dow university hospital, Dow university of health sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Dexmedetomidine; Nalbuphine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

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: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Anesthesiology

Model Details: prospective, randomized, parallel-group, double-blinded clinical trial

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 31, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)