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

NCT07426081 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: PH/IRB/2024/020Patel Hospial
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The PONV scores over the 24-hour period

  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.

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

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Intravenous dexmedetomidine administered perioperatively for prevention of postoperative nausea and vomiting.

Drug: Dexamedomedine

Dexmathasone group

ACTIVE COMPARATOR

Intravenous dexamethasone administered perioperatively for prevention of postoperative nausea and vomiting.

Drug: Dexamethasone

Interventions

Dexamedomedine DRUG

Intravenous dexmedetomidine administered perioperatively.

Dexmedetomidine group

Dexamethasone DRUG

Intravenous dexamethasone administered perioperatively.

Dexmathasone group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patel Hospital, Pakistan: lead

Study Sites (1)

Marium Rafiq

Karachi, Pakistan

Location

Related Publications (12)

• 12. Bajaj V, Singh S, Sharma R, Taank P, Dwivedi D. Effect of palonosetron monotherapy versus palonosetron with dexamethasone combination therapy for prevention of post operative nausea vomiting in children undergoing strabismus surgery. Int J Biomed Res. 2019 Feb 14;10(2):e5080

  BACKGROUND

• 11. Bakri MH, Ismail EA, Ibrahim A. Comparison of dexmedetomidine and dexamethasone for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Korean J Anesthesiol. 2015 Jun;68(3):254-60.

  BACKGROUND

• 10. Khadka B, Sharma NR. A Prospective comparative study of dexmedetomidine and dexamethasone for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. J Soc anesthesiol Nepal. 2021 Jul 5;8(1):e307.

  BACKGROUND

• 9. Gul G, Bilgic T, Aydin MA. Evaluation of the effects of preoperative dexamethasone administration on postoperative patient comfort in laparoscopic cholecystectomy. Cureus. 2020 May 5;12(5):7968.

  BACKGROUND

• 8. Jamil K, Qaisar R. The effect of dexamethasone on postoperative pain in patients after laparoscopic cholecystectomy. Cureus. 2022 Nov 30;14(11):e32067.

  BACKGROUND

• 7. Masoori TA, Gupta K, Agarwal S, Bansal M, Zuberi A, Samad A. Clinical efficacy of dexmedetomidine in two different doses to attenuate the hemodynamic changes during laparoscopic cholecystectomy. Int J Res Med Sci. 2018 Mar;6:959-65.

  BACKGROUND

• 6. Jin S, Liang DD, Chen C, Zhang M, Wang J. Dexmedetomidine prevent postoperative nausea and vomiting on patients during general anesthesia: a PRISMA-compliant meta-analysis of randomized controlled trials. Medicine. 2017 Jan;96(1):e5770.

  BACKGROUND

• 5. Stoops S, Kovac A. New insights into the pathophysiology and risk factors for PONV. Best Practice & Research Clinical Anaesthesiology. 2020 Dec 1;34(4):667-79.

  BACKGROUND

• 4. Sinha V, Vivekanand D, Singh S. Prevalence and risk factors of post-operative nausea and vomiting in a tertiary-care hospital: a cross-sectional observational study. Med J Armed Forces India. 2022 Sep;78(Suppl 1):S158-62.

  BACKGROUND

• 3. Singh M, Tiwari AB, Taank P, Singh S, Kaur A, Sood M, et al. Comparative study on effects of dexmedetomidine and dexamethasone on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic surgery. J Acute Dis. 2022 Apr 1;11(2):59-64.

  BACKGROUND

• 2. Reddy GS, Manjusruthi B, Jyothsna G. Postoperative nausea and vomiting prophylaxis: a comparative study of ramosetron and palonosetron in patients Undergoing Laparoscopic Cholecystectomy - A Prospective Randomized Trial. Anesth Essays Res. 2019 Jan-Mar;13(1):68-72.

  BACKGROUND

• 1. Amreek FN, Hussain SZ, Mnagi MH, Rizwan A. Retrospective analysis of complications associated with laparoscopic cholecystectomy for symptomatic gallstones. Cureus. 2019 Jul 16;11(7):e5152.

  BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Trainee, Department of Anaesthesiology, Principal Investigator

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 23, 2026
• Study Start: June 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)