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

Assiut University

Status and phase: Begins enrollment this month; Phase 4

Conditions: Postoperative Nausea and Vomiting (PONV)

Treatments: Drug: Granisetron

Study type: Interventional

Funder types: Other

Identifiers

NCT07360431

GRAN-PONV-LC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups

Granisetron + Dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Granisetron

Granisetron + Metoclopramide

Experimental group

Description:

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

Treatment:

Drug: Granisetron