Comparing the effect of Neostigmine and Sugammadex on hemodynamic parameters in patients undergoing Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- to compare the effect of sugammadex and neostigmine on heart rate , blood pressure, mean arterial pressure, oxygen saturation, and QTc interval on ECG.
研究概览
简要总结
In this study we are comparing the effect of two drugs sugammadex and neostigmine. both drugs are being used in reversing steroidal non depolarizing muscle relaxants in general anesthesia.
In this study we will be comparing its effects on heart rate , blood pressure , systolic blood pressure, diastolic blood pressure ,mean arteriaL pressure, oxygen saturation , QTc interval on ECG.
study will be done among total 112 patients , with 56 patient in each group.
we are doing this study since sugammadex is a newer agent , and comparing with neostigmine which is being routinely used as a reversal agent for neuromuscular blockage in general anesthesia.
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
- •healthy patients with no comorbidities.
- •patients undergoing elective endoscopic nasal sinus surgeries.
排除标准
- •patients with any other comorbidities.
- •patients with cardiopulmonary , renal or hepatic impairments.
- •patients with coagulation disorders.
- •patients with history or ongoing drug abuse or alcohol abuse.
结局指标
主要结局
to compare the effect of sugammadex and neostigmine on heart rate , blood pressure, mean arterial pressure, oxygen saturation, and QTc interval on ECG.
时间窗: every minute for first 10 minutes, every 10 minutes for first hour , hourly intervals for 24 hours.
次要结局
- to assess the incidence of reintubation.(to assess any adverse effects like -anaphylactic reactions, post extubation stridor, post operative nausea vomiting.)
研究者
Dr Farwa Al Bathool
Dr Moopens Medical College