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临床试验/CTRI/2024/12/078531
CTRI/2024/12/078531尚未招募不适用

Comparison Of Ondansetron and Granisetron in Prevention of Post Operative Nausea and Vomiting in Patients undergoing Surgery Under General Anaesthesia at a Tertiary Care Centre

Vilasrao Deshmukh Government medical college,Latur1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年1月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
The Proportion of Participants achieving PONV score of 3 at 30 minutes to 48 hours with ondansetron and granisetron.

研究概览

简要总结

Objective: To compare the efficacy and incidence of ondansetron and granisetron for control of PONV in patients undergoing surgery under general anesthesia and to study and compare adverse effects caused by these drugs.

Methods: Informed consent will be obtained, and data on demographics, comorbidities, and clinical findings will be recorded. Patients will fast for 8–10 hours and complete a pre-anesthetic interview. Baseline vitals will be recorded before surgery.Participants will be randomized using sealed envelopes Group 1 : 2 mg Granisetron IV 2 minutes before induction and Group 2: 4 mg Ondansetron IV 2 minutes before induction.Anesthesia will be induced with Propofol and Scholine, maintained with nitrous oxide, oxygen, and isoflurane, with Vecuronium as needed. Post-surgery, reversal agents will be given, and patients extubated. PONV scores and vitals will be monitored at regular intervals (30 min, 1, 6, 12, 24, 48 hours) postoperatively by a blinded observer. This study compares the effectiveness of Ondansetron and Granisetron, two commonly used antiemetic drugs, in preventing postoperative nausea and vomiting (PONV) in patients undergoing surgery under general anesthesia. By evaluating their efficacy, duration of action, safety profiles, and patient outcomes, the research aims to guide the selection of the optimal antiemetic for improved postoperative care and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA)Physical status I and II.
  • Age between 18-60 years of either sex.
  • Patients Undergoing Elective Surgeries under General anesthesia.

排除标准

  • Age more than 60 or less than 18 years.
  • Patient Of ASA grade 3 and above.
  • Those not willing to participate in the study.

结局指标

主要结局

The Proportion of Participants achieving PONV score of 3 at 30 minutes to 48 hours with ondansetron and granisetron.

时间窗: 48 hours

次要结局

  • To explore any clinical factors that may influence treatment response.(48 hours)

研究者

发起方
Vilasrao Deshmukh Government medical college,Latur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr KRISHNAKANT BIBHISHAN THOMBRE

Vilasrao Deshmukh Government Medical College

研究点 (1)

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