Comparison Of Sugammadex With Neostigmine For Respiratory Muscle Strength Recovery After Neuromuscular Blockade
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change in diaphragm excursion from baseline (before induction of anaesthesia) to postextubation in both the groups.
研究概览
简要总结
Introduction: Use of neuromuscular blocking agents in general anaesthesia has been linked to postoperative residual curarization (PORC) which is associated with various postoperative pulmonary complications.Ultrasonography can be used as an alternative to acceleromyography for the assessment of PORC. Sugammadex is reported to provide more complete and faster reversal of rocuronium based neuromuscular blockade in comparison to neostigmine.
Aim of Study: To compare the recovery of respiratory muscle strength using ultrasonography after reversal of rocuronium-induced neuromuscular blockade with sugammadex versus neostigmine in the post extubation period.
Materials & methods: A prospective randomized double blinded study will be conducted on 50 adult patients posted for microlaryngeal surgery under general anaesthesia after obtaining a written informed consent. Enrolled patients will be randomly divided into two equal groups to receive either sugammadex 2mg/kg or neostigmine 0.05mg/kg with glycopyrolate 0.01 mg/kg as reversal agent at end of surgery. Ultrasonography will be performed to measure diaphragm excursion (DIA) and thickening fraction of internal oblique muscle (TFIO) before induction of anaesthesia (baseline level), postextubation at train of four ratio (TOFR) ≥ 0.9 in the OR, and at 30 minutes in the PACU. Outcomes of the study are change in DIA and change in TFIO from baseline to postextubation (at TOFR ≥ 0.9) and from baseline to 30 minutes in the PACUin both the groups. The data thus collected will be statistically analysed.
Clinical Significance: Residual neuromuscular blockade is prevalent but often underdiagnosed, therefore adequate prevention is necessary for better outcomes and lesser complications. Adequate reversal of the effect of muscle relaxants and assessment of muscle strength recovery in the postanaesthesia period is essential to avoid residual neuromuscular blockade.
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 scheduled for microlaryngeal surgeries.
- •18 to 65 years.
- •American Society of Anaesthesiologists (ASA) Physical Status Grade I-III
- •Either gender.
排除标准
- •Pregnancy
- •BMI more than 35kg/m2
- •History of allergy to drugs used in study
- •Patient with severe liver (Child Pugh B or C class), renal (stage 4 kidney disease or higher), cardiac disease and/or rhythm disorder
- •Patient requiring postoperative reintubation, tracheostomy or mechanical ventilation.
- •Known or suspected neuromuscular disease
- •Patient’s refusal to participate in the study.
结局指标
主要结局
The change in diaphragm excursion from baseline (before induction of anaesthesia) to postextubation in both the groups.
时间窗: Post extubation
次要结局
- 1 The change in diaphragm excursion from baseline to at 30 minutes in PACU in both the groups(2 The change in thickening fraction of internal oblique from baseline to post extubation & at 30 minutes in PACU in both the groups)
研究者
Dr Richa Jain
Department of Anaesthesia