Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy

NCT07360431 | Not Yet Recruiting Phase 4

• 1 other identifier: GRAN-PONV-LC
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative nausea and vomiting (PONV) remain common and distressing complications following laparoscopic cholecystectomy, particularly in female patients. This randomized interventional study aims to evaluate the effectiveness of preoperative granisetron when combined with either dexamethasone or metoclopramide in preventing PONV. The study compares the incidence and severity of nausea and vomiting, as well as the need for rescue antiemetic therapy, among female patients undergoing laparoscopic cholecystectomy under general anesthesia.

Conditions

Postoperative Nausea and Vomiting (PONV)

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting (PONV)

  The incidence of postoperative nausea and vomiting (PONV) will be recorded and compared between the two study groups.

  0-24 hours postoperatively

Secondary Outcomes (5)

• Severity of postoperative nausea

  0-24 hours postoperatively

• Number of vomiting or retching episodes

  0-24 hours postoperatively

• Requirement for rescue antiemetic medication

  0-24 hours postoperatively

• Patient satisfaction score

  0-24 hours postoperatively

• Incidence of adverse effects

  0-24 hours postoperatively

Study Arms (2)

Granisetron + Dexamethasone

EXPERIMENTAL

Patients will receive granisetron preoperatively, followed by dexamethasone administered after induction of anesthesia for prevention of postoperative nausea and vomiting.

Drug: Granisetron

Granisetron + Metoclopramide

EXPERIMENTAL

Patients will receive granisetron preoperatively, followed by metoclopramide administered after induction of anesthesia for prevention of postoperative nausea and vomiting.

Drug: Granisetron

Interventions

Granisetron DRUG

Granisetron will be administered intravenously preoperatively for prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy.

Granisetron + Dexamethasone; Granisetron + Metoclopramide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: This study includes female participants only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 1- Adult female. 2- (ASA I-II), aged 18-60 years. 3- Non smoker. 4- Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
• Use of intraoperative opioid analgesics.

You may not qualify if:

• History of hypersensitivity to study drugs. 2- Chronic antiemetic. 3- Antidepressant use. 4- Gastrointestinal disease. 5- Pregnancy/lactation. 6- Severe hepatic/renal dysfunction

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Amir Mohamed Abd El Halim Mokhimar

CONTACT

+201030244202; amirmohamed13.16@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design with identical preparation and administration of study medications to maintain blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiogy Resident

Model Details: This is a randomized, double-blind, parallel-group clinical trial evaluating the preventive effect of granisetron plus dexamethasone versus granisetron plus metoclopramide on the prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 22, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share