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临床试验/NCT07360431
NCT07360431尚未招募4 期

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

Assiut University0 个研究点目标入组 102 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
102

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double-blind design with identical preparation and administration of study medications to maintain blinding.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - 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.

排除标准

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amir Mohamed Abd El Halim Mokhimar

Anesthesiogy Resident

Assiut University

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