Impact of reversal of neuromuscular blockade with Sugammadex vs Neostigmine on early postoperative respiratory muscle function in geriatric population
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare postoperative Pulmonary function after neuromuscular blockade reversal associated with the use of Sugammadex and Neostigmine
研究概览
简要总结
This study is a comparative observational analysis evaluating the effectiveness of Sugammadex versus Neostigmine in reversing Vecuronium-induced neuromuscular blockade in patients aged over 65 years undergoing surgery under general anaesthesia. It aims to assess postoperative pulmonary function and residual blockade using spirometry, train-of-four monitoring, and diaphragm ultrasonography up to two hours postoperatively.
The study includes 100 patients, divided equally into two groups receiving either Sugammadex 2 mg/kg or Neostigmine 0.05 mg/kg with glycopyrrolate. Parameters such as inspiratory volume, TOF ratio, diaphragm contractility, and clinical recovery indicators are measured at set intervals post-reversal. The goal is to determine which agent ensures faster and more complete recovery with fewer respiratory complications, especially in the elderly.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 65.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologist Physical Status I-III
- •Scheduled for a surgical procedure under general anaesthesia requiring endotracheal intubation
- •Anaesthesia induction with Vecuronium as NMBA.
排除标准
- •Anticipation of a difficult airway
- •Known or suspected neuromuscular disorders, significant renal dysfunction, known or suspected family history of malignant hyperthermia, and allergies to narcotics, muscle relaxants, or other medications used during general anaesthesia
- •Patients receiving medication at a dose and/or time-point likely to interfere with NMBDs and in whom the use of Neostigmine and/or glycopyrrolate could be contraindicated
- •Those with diaphragm insufficiency or massive pleural effusion
- •Those undergoing upper abdominal laparotomy will be excluded after which we cannot obtain a satisfactory ultrasound imaging or do not have space for the placement of the ultrasound probe.
结局指标
主要结局
To compare postoperative Pulmonary function after neuromuscular blockade reversal associated with the use of Sugammadex and Neostigmine
时间窗: 10,30,60 and 120 minutes
次要结局
- To evaluate the residual neuromuscular blockade effect of Vecuronium after reversal with Sugammadex compared to Neostigmine up to 2 hours postoperatively.(10,30,60 and 120 minutes)
研究者
Amriish Garg
Himalayan Institute of Medical Sciences, Jolly Grant, Dehradun