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

Preoperative Granisetron in Combination With Dexamethasone or Metoclopramide for Prevention of Postoperative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Nausea and Vomiting (PONV)
• Intervention / Treatment: Drug: Granisetron

Detailed Description

Postoperative nausea and vomiting (PONV) are among the most frequent complications after laparoscopic cholecystectomy and are associated with patient discomfort, delayed recovery, prolonged hospital stay, and decreased patient satisfaction. Female gender, laparoscopic surgery, and the use of general anesthesia are well-recognized risk factors for PONV.

Granisetron, a selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, has proven efficacy in the prevention of PONV. Combining granisetron with other antiemetic agents that have different mechanisms of action, such as dexamethasone or metoclopramide, may enhance its antiemetic effect through a multimodal approach.

This prospective randomized interventional study is designed to compare the efficacy of preoperative granisetron combined with dexamethasone versus granisetron combined with metoclopramide in preventing PONV in female patients undergoing laparoscopic cholecystectomy under general anesthesia. Eligible patients will be randomly allocated into two groups to receive either granisetron with dexamethasone or granisetron with metoclopramide prior to induction of anesthesia.

The primary outcome measure will be the incidence of postoperative nausea and vomiting within the first 24 hours after surgery. Secondary outcomes will include the severity of nausea, frequency of vomiting episodes, requirement for rescue antiemetic medications, and the occurrence of any adverse effects related to the study drugs.

The results of this study aim to identify the more effective granisetron-based combination for PONV prophylaxis in this high-risk population, potentially contributing to improved postoperative care and patient satisfaction following laparoscopic cholecystectomy.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amir Mohamed Abd El Halim Mokhimar; Phone Number: +201030244202; Email: amirmohamed13.16@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

5- Use of intraoperative opioid analgesics.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Granisetron + Dexamethasone; Patients will receive granisetron preoperatively, followed by dexamethasone administered after induction of anesthesia for prevention of postoperative nausea and vomiting.	Drug: Granisetron; Granisetron will be administered intravenously preoperatively for prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy.
Experimental: Granisetron + Metoclopramide; Patients will receive granisetron preoperatively, followed by metoclopramide administered after induction of anesthesia for prevention of postoperative nausea and vomiting.	Drug: Granisetron; Granisetron will be administered intravenously preoperatively for prevention of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postoperative nausea	Severity of nausea will be assessed using a visual analog scale (VAS) ranging from 0 to 10.	0-24 hours postoperatively
Number of vomiting or retching episodes	The total number of vomiting or retching episodes will be recorded for each patient.	0-24 hours postoperatively
Requirement for rescue antiemetic medication	The need for rescue antiemetic medication will be recorded during the postoperative period.	0-24 hours postoperatively
Patient satisfaction score	Patient satisfaction with postoperative nausea and vomiting management will be assessed using a satisfaction scoring system.	0-24 hours postoperatively
Incidence of adverse effects	The incidence of adverse effects including headache, dizziness, and extrapyramidal symptoms will be recorded.	0-24 hours postoperatively

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Indazoles; Pyrazoles; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Granisetron
• Other Study ID Numbers: GRAN-PONV-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes