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NCT Number: NCT07360431

Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After 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.

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Key information

Conditions

Postoperative Nausea and Vomiting (PONV) Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granisetron

Drug

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

Primary outcomes

  1. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: 0-24 hours postoperatively

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

Secondary outcomes

  1. Severity of postoperative nausea

    Time frame: 0-24 hours postoperatively

    Severity of nausea will be assessed using a visual analog scale (VAS) ranging from 0 to 10.

  2. Number of vomiting or retching episodes

    Time frame: 0-24 hours postoperatively

    The total number of vomiting or retching episodes will be recorded for each patient.

  3. Requirement for rescue antiemetic medication

    Time frame: 0-24 hours postoperatively

    The need for rescue antiemetic medication will be recorded during the postoperative period.

  4. Patient satisfaction score

    Time frame: 0-24 hours postoperatively

    Patient satisfaction with postoperative nausea and vomiting management will be assessed using a satisfaction scoring system.

  5. Incidence of adverse effects

    Time frame: 0-24 hours postoperatively

    The incidence of adverse effects including headache, dizziness, and extrapyramidal symptoms will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Amir Mohamed Abd El Halim Mokhimar

CONTACT

[email protected]

+201030244202

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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