Comparison of sugammadex and neostigmine for reversal of vecuronium induced neuromuscular blockade in elderly patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To determine the time taken from start of study drug injection to train of four 0.9 ratio
研究概览
简要总结
In this study 96 elderly patients (age >60 years) posted for elective surgeries requiring general anesthesia will be included. After taking written informed consent, patients will be randomized into two groups (group A (n=48) and group B (n=48)).
General anaesthesia will be started with preoxygenation with 100% O2 for over 3 minutes. Premeditation, such as Glycopyrrolate(0.2mg), midazolam(1mg) and fentanyl(2mcg/kg) will be given.Then induction will be started by giving titrated doses of propofol (1.5-2 mg/kg).
A single bolus dose of vecuronium (0.1 mg/kg) is given, then intubation is done at TOF count 0(zero). Maintenance of anaesthesia is by giving isoflurane, oxygen and/or nitrous oxide.
Maintenance doses of vecuronium (0.02 mg/kg) will be administered as needed at reappearance of the second twitch (T2 ) on the TOF monitor or if clinically required.
At the end of surgery after reappearance of T3, either sugammadex 2 mg/kg or neostigmine 50ug/kg plus glycopyrrolate 10 ug/kg will be administered in a randomized order as an IV bolus within 10s.
Immediately after tracheal extubation, we will note the time to get TOF ratio 0.9. Then patient will be shifted to PACU(post anaesthesia care unit).
In PACU for every 20 minutes upto one hour we will observe for 5 second head lift, level of consciousness and train of four ratio(TOF) to check for any PORC( postoperative residual curarization).
Also any residual side effects like nausea ,vomiting, headache, dry mouth, altered taste, bradycardia will be noted.
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
- 60.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective surgeries of age greater than 60 years and patients of ASA 1 and ASA 2.
排除标准
- •Patients who are not willing to give consent for the study, patient known allergic to narcotics, muscle relaxants, or other medication used during general anaesthesia, patients with anticipation of difficult airway, patients on drugs which are known to interact with neuromuscular blocking drugs, patients with significant renal dysfunction, patients who are known or suspected neuromuscular disorders.
结局指标
主要结局
To determine the time taken from start of study drug injection to train of four 0.9 ratio
时间窗: Check train of four count every twenty minutes for one hour
次要结局
- Look for other adverse effects of the drug such as nausea, vomiting, altered taste(Check for every twenty minutes for one hour)
研究者
Dr GUNDA RAVI SHANKER REDDY
Institute of medical sciences, SUM hospital