Comparative study of the efficacy of two different dosage of cisatracurium for endotracheal intubation during rapid sequence induction of anesthesia. A prospective randomized double blind study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the time of onset of action of two different doses of cisatracurium for
研究概览
简要总结
Rapid sequence induction of anaesthesia, commonly used in emergency surgeries to secure airway rapidly by endotracheal intubation to minimize the risk of aspiration and hypoxia.
Succinylcholine and large doses of rocuronium has been used as a standard drug for rapid sequence induction of anaesthesia. However, many adverse effects associated with succinylcholine and Rocuronium prompted the search for alternate drug.
The dose of atracurium required for rapid sequence induction can be associated with significant cardiopulmonary adverse events due to histamine release. Cisatracurium , a sterioisomer of atracurium shares the same metabolic pathway as atracurium with minimal release of histamine after bolus administration.
Hence this study aims to compare the efficacy and duration of two different doses of cisatracurium in combination with fentanyl, propofol and lignocaine for rapid sequence induction of anesthesia in patients undergoing elective surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiology (ASA) physical status I and II.
- •Patient undergoing elective surgery lasting more than two hours under general anaesthesia.
- •Patients with no known neuromuscular diseases.
- •Patient not undergoing treatment with medications known to interfere with neuromuscular transmission.
- •Patient willing to give the written consent to participate in the study.
排除标准
- •Patients who refuse to give consent to the study.
- •Patients who is a known smoker, asthmatic and COPD.
- •Patients with anticipated difficulty airway.
- •Patients with known allergies to the study drug.
- •Pregnant and lactating women.
结局指标
主要结局
To compare the time of onset of action of two different doses of cisatracurium for
时间窗: 1)Onset of neuromuscular block will be assessed with TOF stimulus every 12 seconds until loss of twitch response (TOF-0). | 2)The blood pressure, heart rate will be recorded every minute for 10 minutes, followed by monitoring every five minutes after endotracheal intubation till the end of surgery. But statistical comparision will be done up to 30 minutes. | 3)After the endotracheal tube fixation, TOF stimulation will be recorded every 5 minutes until the return of two twitches (TOF-25).
rapid sequence induction of anesthesia as an indicator of efficacy.
时间窗: 1)Onset of neuromuscular block will be assessed with TOF stimulus every 12 seconds until loss of twitch response (TOF-0). | 2)The blood pressure, heart rate will be recorded every minute for 10 minutes, followed by monitoring every five minutes after endotracheal intubation till the end of surgery. But statistical comparision will be done up to 30 minutes. | 3)After the endotracheal tube fixation, TOF stimulation will be recorded every 5 minutes until the return of two twitches (TOF-25).
次要结局
- • To compare the duration of action of the two doses of cisatracurium administered for the rapid sequence induction.(• To compare the intubating conditions during endotracheal intubation using Copenhagen consensus conference scoring system.)
研究者
DR B Kesava Kumar
Sri Venkateswara Institute of Medical Sciences