Study of Effects of Neostigmine Versus Sugammadex in Ultrasonographic Evaluation of Recovery of Diaphragmatic Function After General Anesthesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline values
研究概览
简要总结
The aim of our study is to assess differences in the recovery of muscle function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex
详细描述
Post-operative residual curarization (PORC) remains an essential clinical challenge. The possibility of assessing muscle function and excluding PORC using noninvasive tools in the perioperative period is very attractive. Therefore, we used diaphragm ultrasonography.
The diaphragm is a major respiratory muscle, accounting for 60-70% of the respiratory workload. Its dysfunction involves post-operative respiratory failure.
Diaphragm ultrasound imaging is a cheap and portable technique that allows assessment of diaphragm thickness, thickening, and excursion at a point in time or over time, in ambulatory patients and in mechanically ventilated patients.
Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization.
This study was designed to assess differences in the recovery of the diaphragmatic function, using diaphragm ultrasonography, after reversal of a rocuronium-induced block, using neostigmine versus sugammadex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with American Society of Anesthesiologists' (ASA) physical status I or II or III
- •Adult patients aging (18-65) years of both sexes. who undergoing deep neuromuscular block with rocuronium.
- •Patients Scheduled for elective FISS surgery
排除标准
- •Patient's refusal of procedure or participation in the study.
- •ASA class IV.
- •History of hepatic disease (Child Pugh B or C class).
- •History of renal disease.
- •Allergy or hypersensitivity to sugammadex or neostigmine.
- •History of neuromuscular disease.
- •Diaphragmatic palsy, pregnancy, nursing.
研究组 & 干预措施
sugammadex
Group A: receive sugammadex (SUG group) as the reversal drug
干预措施: sugammadex (Drug)
neostigmine
receive neostigmine (NEO group) as reversal drug.
干预措施: Neostigmine (Drug)
结局指标
主要结局
the difference between diaphragmatic thickening fraction at 30 minuets vs. The corresponding baseline values
时间窗: By using diaphragmatic ultrasonography baseline diaphragmatic thickening fraction preoperative and at Zero time, 10 minutes, and 30 minutes in Post anesthesia care unit
Prior to induction of anesthesia, baseline thickening fractioning evaluated using diaphragmatic ultrasonography, All patients were given general anesthesia, after pre-oxygenation induction of anesthesia was started using fentanyl and propofol. Intubation was done with proper size endotracheal tube after relaxation provided by rocuronium, At the end the operation patients received the reversal drug according to the group to which they had been randomised. Immediately prior to extubation, diaphragm ultrasonography was carried out to assess muscle recovery in each patient during spontaneous breathing. Two additional diaphragm ultrasound sessions were carried out 10 minutes and 30 minutes after discharge from the operating theatre, while the patients are in the post anesthesia care unit.
次要结局
未报告次要终点