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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07426081
Enrollment
68
Registered
2026-02-23
Start date
2025-06-01
Completion date
2025-11-15
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative nausea and vomiting, Dexmedetomidine, Dexamethasone, Laparoscopic cholecystectomy, Randomized controlled trial

Brief 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.

Interventions

Intravenous dexmedetomidine administered perioperatively.

DRUGDexamethasone

Intravenous dexamethasone administered perioperatively.

Sponsors

Patel Hospital, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

1. Both male and female patients will be included 2. Patient between the age of 18 to 60 years. 3. Patient undergoing elective Laparoscopic Cholecystectomy. 4. Patients with American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion criteria

1. Patient not willing to participate in study. 2. Patients with a history of allergy to dexmedetomidine and dexamethasone. 3. Patients having motion sickness and history of PONV in past anesthesia experience. 4. Patients receiving antiemetic drugs during the last 48 hours before laparoscopic cholecystectomy. 5. Patients with body mass index ≥ 30 kg/m2 6. Patients with emergency laparoscopic cholecystectomy. 7. Laparoscopic cholecystectomy lasts for more than one hour. 8. Laparoscopic cholecystectomy converting to open cholecystectomy.

Design outcomes

Primary

MeasureTime frameDescription
The PONV scores over the 24-hour periodFrom 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026