Comparing the speed of reversal of neuromuscular blockade by combination of Sugammadex and neostigmine with neostigmine alone in patients undergoing laparoscopic surgery
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- To estimate and compare the time to reach TOF ratio more than 0.9 by using (neostigmine + sugammadex) vs (neostigmine) by objective parameters such as TOFR.
研究概览
简要总结
This study is a randomized, double blinded, parallel group, single-centre trial comparing the speed of reversal of neuromuscular blockade by combination of sugammadex and neostigmine with neostigmine alone in patients undergoing laparoscopic surgery. The primary outcome is to estimate and compare the time to reach TOF ratio more than 0.9 by using ( neostigmine + sugammadex ) vs (neostigmine) by objective paramters such as TOFR. The secondary outcomes will be to estimate and compare time to spontaneous breathing, time to extubation, incidence of RNMB in both groups using TOF and diaphragm ultrasound at 3 time points- Baseline at TOF>0.9, 30 min after shifting to PACU - diaphragm excursion using M mode at rest and deep breathing.
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
- •ASA physical status 1 and 2, between 18-65 years scheduled to undergo laparoscopic surgery.
排除标准
- •1.Allergy to study drugs 2.BMI more than 30 3.Serum creatinine more than 2.0 mg per dL 4.Patients taking hormonal birth control pills.
- •5.Breastfeeding mothers 6.Patients with anticipated difficult airway 7.Patients with suspected or known to have neuromuscular disorders.
- •8.H/o malignant hyperthermia Patients receiving medication at a dose or time known to interfere with NMBAs.
结局指标
主要结局
To estimate and compare the time to reach TOF ratio more than 0.9 by using (neostigmine + sugammadex) vs (neostigmine) by objective parameters such as TOFR.
时间窗: Endoperative period
次要结局
- To estimate and compare time to spontaneous breathing(Endoperative period)
- To estimate and compare time to extubation(Endoperative period)
- To estimate and compare incidence of RNMB in both groups using TOF and diaphragm ultrasound - Diaphragm excursion using M mode at rest and deep breathing(Baseline, TOF more than 0.9, 30 min after shifting to PACU.)
研究者
Dr Roshini P A
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)