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Completed
NCT06476600
Opioid-based Versus Opioid-free Anaesthesia for Laparoscopic Cholecystectomy
Conditions: Surgical Procedure, Unspecified, Laparoscopic Cholecystectomy
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 42
Sponsor: Atif Shafqat
Location: Dow university hospital, Dow university of health sciences Karachi Sindh
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.
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent from the participant.
2. All patients who are aged between 18 - 65 years.
3. American Society of Anaesthesiologists (ASA) classification of I and II
4. Elective Laparoscopic cholecystectomies.
Exclusion Criteria:
1. American Society of Anaesthesiologists (ASA) classification of III and above
2. Non-elective surgery
3. Body Mass Index \> 35
4. Patients with regular prescription of Beta-blockers
5. Pregnant or breastfeeding women
6. Allergy to Opioids and/or other drugs used in the trial.
7. Chronic use of opioids or benzodiazepines
8. Chronic pain patients
9. Patients with cardiovascular, renal, hepatic or central nervous system diseases
10. Patients with psychiatric illness
Source: ClinicalTrials.gov (NCT06476600). StuddyBuddy aggregates publicly available trial information.