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临床试验/CTRI/2022/10/046372
CTRI/2022/10/046372招募中不适用

Comparison of the effects of Aprepitant and Dexamethasone on postoperative nausea and vomiting after laparoscopic cholecystectomy: A double blind randomised trial.

Intramural project funded by Research cell of Rajendra Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
84
试验地点
1
主要终点
The primary efficacy variable will be episodes of nausea and vomiting in the early and late postoperative period in first 24 hours.

研究概览

简要总结

Postoperative nausea and vomiting (PONV) is one of the most common postsurgical complications (Myles et al. 2000). It is caused by various factors such as the use of anaesthetics, perioperative use of opioids, the type of surgery, and patient characteristics (Apfel et al. 2003). PONV decreases overall patient satisfaction and is associated with poor surgical outcomes. It extends the hospitalisation period because of delayed recovery and causes fatal complications such as suture laceration, bleeding, increased intracranial pressure, aspiration pneumonia, dehydration and electrolyte imbalance (Gan et al. 2003).

Various classes of medications, including serotonin receptor antagonists and dopamine receptor antagonists are currently used to prevent PONV in patients undergoing laparoscopic cholecystectomy. However, due to increased intra-abdominal pressure during laparoscopy and perioperative use opioids, the risk of PONV increases (Bradshaw et al . 2002). Even after the use of recommended drugs for PONV prophylaxis, patient experiences significant amount of postoperative nausea and vomiting after laparoscopic cholecystectomy.

Aprepitant is a neurokinin-1 receptor antagonist that blocks the emetic effects of substance P (SP) at neurokinin-1 receptors in the gastrointestinal tract. It also inhibits the signals received from the chemoreceptor trigger zone by the nucleus tractus solitarius in the brain stem *(Diemunsch et al. 2009).*Aprepitant has been used to prevent chemotherapy-induced nausea and vomiting. However, its efficacy in PONV prevention in non-chemotherapy patients and elective surgeries is still unexplored.

 In previous literatures, the evidences for analgesic property of Aprepitant are few and lacking. Therefore, our hypothesis of considering Aprepitant a better alternative for PONV prevention and pain control can change our practice in anaesthesia. Aprepitant may become a part of multimodal analgesia with additional antiemetic property leading to better patient satisfaction and early discharge.

 However, Dexamethasone is well known for its antiemtic and analgesic properties, its comparison with Aprepitant can bring up new evidences for PONV prevention and pain management in patients undergoing laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA GRADE I & II PATIENTS SCHEDULED FOR ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY SURGERY.

排除标准

  • PATIENTS WHO HAD A HISTORY OF DRUG ABUSE, HYPERSENSITIVITY REACTION, NAUSEA AND RECEIVED ANTIEMETIC BEFORE SURGERY WITHIN 24 HOURS, PREGNANCY, BREASTFEEDING STATUS.

结局指标

主要结局

The primary efficacy variable will be episodes of nausea and vomiting in the early and late postoperative period in first 24 hours.

时间窗: first 24 hours after surgery.

次要结局

  • The incidence of any adverse reaction to treatment in the two experimental groups will be recorded

研究者

发起方
Intramural project funded by Research cell of Rajendra Institute Of Medical Sciences
申办方类型
Research institution and hospital

研究点 (1)

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