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OpenTrials
Completed

NCT Number: NCT07426081

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Marium Rafiq

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Laparoscopic cholecystectomy lasts for more than one hour.
  • Laparoscopic cholecystectomy converting to open cholecystectomy.

Treatment and study plan

Dexamedomedine

Drug

Intravenous dexmedetomidine administered perioperatively.

Dexamethasone

Drug

Intravenous dexamethasone administered perioperatively.

Primary outcomes

  1. The PONV scores over the 24-hour period

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

    PONV will be assessed using the Postoperative Nausea and Vomiting (PONV) Scoring Scale (range: 0-3; higher scores indicate worse outcome, where 0 = no nausea/vomiting and 3 = vomiting ≥3 episodes/day). Assessments will be performed at predefined time points: upon arrival in PACU (0 hours), 4 hours, 12 hours, and 24 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Patel Hospital, Pakistan

Other

Registry information

Official study title

Comparison of Dexmedetomidine and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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