Comparison of sugammadex and neostigmine in adult patients undergoing on table extubation after elective cardiac surgery under combined general and high spinal anaesthesia - A randomized controlled trial study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The time interval from administering the reversal agent to the extubation.
研究概览
简要总结
This study is a randomised, double blinded, parallel group, single centre trial comparing Sugammadex and Neostigmine in adult patients undergoing on table extubation after elective cardiac surgery under combined general and high spinal anaesthesia. The primary outcome will be the time interval from administering the reversal agent to extubation. The secondary outcomes will be time to attain TOF more than 0.9, residual paralysis (TOF less than 0.9), respiratory complications (hypoxemia, hypercarbia), reintubation within 2 hours of extubation, prolonged ICU stay duration, requirement of non-invasive ventilation in ICU within 48 hours.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective cardiac surgery with CPB planned for on table extubation ASA classification 1-3.
排除标准
- •Allergic to Sugammadex or neostigmine or having any contraindications Emergency cardiac surgery Surgery under moderate to deep hypothermia Patient not giving written informed consent Patient with ejection fraction less than 30% ASA classification more than III.
结局指标
主要结局
The time interval from administering the reversal agent to the extubation.
时间窗: immediately
次要结局
- Time to attain TOF more than 0.9.(Residual paralysis (TOF less than 0.9))
研究者
Sunder Lal Negi
Post Graduate Institute of Medical Education and Research Chandigarh