COMPARISON OF SUGAMMADEX VERSUS NEOSTIGMINE TO MEASURE RESPIRATORY MUSCLE STRENGTH RECOVERY POST-EXTUBATION IN ADULTS: A RANDOMISED CONTROLLED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- To compare respiratory muscle strength recovery in sugammadex and neostigmine
研究概览
简要总结
Background and aims
Residual neuromuscular blockade is a common complication after general anesthesia.Commonly used reversal agent, neostigmine, cannot reverse profound neuromuscular blockade, risking postoperative recurarization. Sugammadex, a novel reversal agent, provides complete reversal of deep neuromuscular blockade with lesser adverse effects such as residual neuromuscular blockade and pulmonary complications.
This study aims at evaluating the postoperative respiratory muscle strength recovery in Sugammadex and Neostigmine.
Method
Following institutional ethics approval and informed consent, 38 patients undergoing surgery will be randomized into two groups 19 each, to receive either sugammadex or neostigmine for neuromuscular blockade reversal. Anaesthesia will be standardized across all patients, with neuromuscular monitoring using TOF Watch. Reversal agents will be administered at TOF ratio more than 0.7, and extubation performed once TOFR more than 0.9. Respiratory muscle function including thickness fraction of internal oblique , diaphragm , intercostals , and diaphragmatic excursion will be assessed via ultrasonography at three time points, baseline, post-extubation, and 30 minutes post-extubation. Standard B-mode and M-mode ultrasound techniques will be used, with three repeated measures per muscle, recording the highest value. The study is aimed to compare the efficacy of sugammadex and neostigmine on respiratory muscle recovery post-reversal.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give informed consent (ANNEXURE 1) Patients of age 18-60 years.
- •ASA grade 1 & 2(ANNEXURE 2) Patients undergoing abdominal surgeries.
排除标准
- •American Society of Anesthesiology (ASA) physical status III–IV significant kidney disease (stage 4 kidney disease or higher) significant liver disease (Child-Pugh B or C class) history of chronic obstructive pulmonary disease known or suspected neuromuscular disease arrhythmic disease or use of antiarrhythmic drugs allergy to rocuronium, neostigmine, or sugammadex suspected difficult airway.
结局指标
主要结局
To compare respiratory muscle strength recovery in sugammadex and neostigmine
时间窗: Baseline(before induction of anaesthesia), immediate post extubation, 30 minutes post extubation
次要结局
- To assess time taken from administration of reversal agent to extubation in sugammadex & neostigmine
研究者
Dr Shreya S Hegde
Bangalore Medical College and Research Institute.