CTRI/2025/07/090212尚未招募2/3 期
A randomised prospective comparative study of the effect of neostigmine 0.05mg per kg and sugammadex 2mg per kg on postoperative nausea and vomiting in adult patients under general anaesthesia in ear, nose, throat surgery.
Mysore Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年7月25日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post operative nausea and vomiting
研究概览
简要总结
The study is conducted to compare the effect of Sugammadex and Neostigmine on postoperative nausea and vomiting in adult patients under general anaesthesia in ear nose throat surgery.
We also compare the amount of antiemetics given in the postoperative period and to know about the other side effects caused by these drugs, so that reversal agents can be decided for each case judiciously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant 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
- •ASA grade 1 and 2 patients scheduled for elective ENT surgery with Apfel score 0 to 2 and BMI less than 30kg per m2.
排除标准
- •Patients who were obese (body mass index greater than 30 kg per m2) Pregnant History of PONV Apfel score more than 2 Impaired renal function (creatinine clearance less than 30ml per min) Required postoperative ventilation Allergic to any drugs used in the study Patients who underwent middle ear surgery requiring nerve monitoring.
结局指标
主要结局
Post operative nausea and vomiting
时间窗: 1, 6, 12, 24 hours post operatively.
Amount of antiemetics given
时间窗: 1, 6, 12, 24 hours post operatively.
Any other side effects
时间窗: 1, 6, 12, 24 hours post operatively.
次要结局
- Total antiemetic dosage administered and to assess the side effects after reversal with neostigmine and sugammadex in 24 hours.(24 hours)
研究者
Sarayu M Suresh
Mysore Medical College and Research Institute
研究点 (1)
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