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Opioid-based Versus Opioid-free Anaesthesia for Laparoscopic Cholecystectomy
Sponsor: Atif Shafqat
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.
Official title: Opioid-based (OA) Versus Opioid-free Anaesthesia (OFA) for General Surgical Procedures in a Developing Country
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2024-07-01
Completion Date
2024-10-31
Last Updated
2026-07-08
Healthy Volunteers
Yes
Interventions
Dexmedetomidine injection
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.
Nalbuphine Injection
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.
Locations (1)
Dow university hospital, Dow university of health sciences
Karachi, Sindh, Pakistan