Comparison of standard clinical assessment based decision with Quantitative Neuromsucular monitor guidance for evaluation of the adequacy of neuromuscular recovery before tracheal extubation and Its Impact on Postoperative spirometry in Patients Undergoing General anaesthesia.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- a) Compare postoperative Forced Vital Capacity (FVC) and Peak Expiratory Flow (PEF) reductions in the immediate first hour postoperative period in patients with RNMB following the reversal strategy either using TOF monitor versus standard conventional clinical judgment.
研究概览
简要总结
This study is a randomized controlled trial to compare standard clinical assessment-based decision-making with quantitative neuromuscular monitor guidance for evaluating the adequacy of neuromuscular recovery before tracheal extubation and its impact on postoperative spirometry in patients undergoing general anesthesia. The study will be conducted at the Pondicherry Institute of Medical Sciences (PIMS), a 740-bed multi-specialty hospital and teaching institute in Ganapathichettikulam, Puducherry.
The primary outcome is to compare the quantitative impact of residual neuromuscular blockade (RNMB) on postoperative pulmonary function in patients undergoing elective surgery under general anesthesia with endotracheal intubation using Train of Four (TOF) monitoring versus standardized clinical assessment-based recovery of neuromuscular blockade. This includes
a) Compare postoperative Forced Vital Capacity (FVC) and Peak Expiratory Flow (PEF) reductions in the immediate first-hour postoperative period in patients with RNMB following the reversal strategy using either a TOF monitor or standard conventional clinical judgment.
b) Compare the number of patients with residual NMB in both groups and the time to achieve a TOF of 1.0 post-extubation in the Post-Anesthesia Care Unit (PACU).
The secondary outcome is to compare the following parameters between the two groups: hypoxia (SpO2 less than 90%), respiratory distress (RR > 30), and upper airway obstruction.
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
- •American society of anaesthesiology (ASA) physical status I and II undergoing elective surgery under general anaesthesia.
排除标准
- •Patients with ASA status III and above,Pregnant women,Patients with history of neuromuscular diseases,on medications that interfere with neuromuscular junction function,renal, hepatic or respiratory disease,BMI greater than 35kg per m2,Pre operative hypothyroidism,undergoing brain or thoracic surgery.
结局指标
主要结局
a) Compare postoperative Forced Vital Capacity (FVC) and Peak Expiratory Flow (PEF) reductions in the immediate first hour postoperative period in patients with RNMB following the reversal strategy either using TOF monitor versus standard conventional clinical judgment.
时间窗: a) PFT - Preoperatively baseline and 30 mins,1hr,1hr 30 mins, 2hrs postoperatively | b) TOF ratio - every 5 mins upto 1 hr
b) Number of patients with residual NMB in both the groups and time to achieve TOF of 1.0 post extubation in PACU
时间窗: a) PFT - Preoperatively baseline and 30 mins,1hr,1hr 30 mins, 2hrs postoperatively | b) TOF ratio - every 5 mins upto 1 hr
次要结局
- To compare the following parameters between the 2 groups adverse respiratory events 1) Hypoxia (SpO2 less than 90%) 2) Respiratory distress RR greater than 30 3) upper airway obstruction(2 hr)
研究者
Dr MV Vidya
Pondicherry Institute of Medical Sciences