Opioid-based Versus Opioid-free Anaesthesia for Laparoscopic Cholecystectomy
NCT Number: NCT06476600
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Procedure, Unspecified|Laparoscopic Cholecystectomy
Interventions: DRUG: Dexmedetomidine injection|DRUG: Nalbuphine Injection
Sponsor: Atif Shafqat
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-02-20
Completion Date: 2024-08-31
Locations: Dow university hospital, Dow university of health sciences, Karachi, Sind, Pakistan

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.

Primary Outcome Measures: 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 Outcome Measures: Intraoperative haemodynamic stability, Systolic blood pressure (SBP) and Mean arterial pressure (MAP), Measured from start to end of anaesthesia|Intraoperative haemodynamic stability, Bradycardia (Heart Rate \< 50 beats per minute), Measured from start to end of anaesthesia|Intraoperative haemodynamic stability, Hypotension (SBP \<80 mmHg or MAP \<60 mmHg), Measured from start to end of anaesthesia|Anaesthesia and recovery clinical outcomes, Pain Scores measured by visual analogue scale (VAS), where 0 = no pain and 10 = worst pain, with 'sad' or 'happy' pictures at each end., Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Nausea (yes/no), Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Vomiting (yes/no), Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Rescue Antiemetic drug, Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Shivering (yes/no), Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Pruritis (yes/no), Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Level of Sedation. I-awake; II-sedated and responsive to verbal stimuli; III-sedated and unresponsive to verbal stimuli., Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Respiratory depression, Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Delirium and Hallucinations (yes/no), Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Rescue Analgesia, Measured at end of anaesthesia in post anaesthesia care unit and at 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Time to first analgesia (minutes), Measured at end of anaesthesia in post anaesthesia care unit or 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Time to mobilize post-operatively (minutes), Measured at end of anaesthesia in post anaesthesia care unit or 24 hours postoperatively.|Anaesthesia and recovery clinical outcomes, Length of stay in post anaesthesia care unit \[PACU\] (minutes), From Time of PACU admission to time of PACU discharge|Anaesthesia and recovery clinical outcomes, Overall length of stay (LOS) (minutes), From Time of theatre entrance to time of discharge from the hospital|Anaesthesia and recovery clinical outcomes, Oral Morphine Equivalent Daily Dose (OMEDD), Measured at start of anaesthesia till discharge from hospital