CompletedPhase 3

Comparison of Dexmedetomidine and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy

Pakistan68 participantsStarted 2025-06-01

Plain-language summary

Postoperative nausea and vomiting (PONV) remains a common and distressing complication after laparoscopic cholecystectomy despite advances in anesthesia. Both dexmedetomidine and dexamethasone have shown antiemetic properties, but their comparative effectiveness is still debated. To compare the efficacy of dexmedetomidine and dexamethasone in preventing PONV in patients undergoing laparoscopic cholecystectomy. This double-blind randomized controlled trial included 68 ASA I-II patients scheduled for elective laparoscopic cholecystectomy. Patients were randomly allocated to receive either intravenous dexmedetomidine (1 μg/kg) or dexamethasone (8 mg) after induction of anesthesia. PONV was assessed using a standardized scoring system on arrival in the PACU and at 4, 12, and 24 hours postoperatively. Ondansetron was administered as rescue antiemetic when required. This study aims to determine the more effective prophylactic agent for PONV, with the goal of improving postoperative comfort and quality of care in patients undergoing laparoscopic surgery in the local population.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Both male and female patients will be included
✓. Patient between the age of 18 to 60 years.
✓. Patient undergoing elective Laparoscopic Cholecystectomy.
✓. Patients with American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion criteria

✕. Patient not willing to participate in study.
✕. Patients with a history of allergy to dexmedetomidine and dexamethasone.
✕. Patients having motion sickness and history of PONV in past anesthesia experience.
✕. Patients receiving antiemetic drugs during the last 48 hours before laparoscopic cholecystectomy.
✕. Patients with body mass index ≥ 30 kg/m2
✕. Patients with emergency laparoscopic cholecystectomy.

What they're measuring

The PONV scores over the 24-hour period

Timeframe: From arrival in the post-anesthesia care unit (0 hours) through 24 hours after surgery, assessed at 0, 4, 12, and 24 hours postoperatively.

Trial details

NCT IDNCT07426081

SponsorPatel Hospital, Pakistan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-15

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