Comparative evaluation of Sugammadex and Neostigmine reversals in preventing post-operative pulmonary complications in chronic obstuctive pulmonary disease - A Prospective , Randomized , Double blinded study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measurement of peak expiratory flow rate in both the groups in the preoperative period and at varied time intervals post operatively
研究概览
简要总结
Chronic obstructive pulmonary disease(COPD) poses specific threats in the post operative period following general anaesthesia. Complications like hypoxemia, atelectasis, pneumonia, inability to clear the secretions and respiratory failure are known problems especially after abdominal surgeries.Laparoscopic abdominal surgeries are safe & effective alternative when compared to open procedures.Laparoscopic approach tend to reduce the incidence of above mentioned complications in COPD patients when compared to open surgeries.Respiratory muscles recovery following neuromuscular blockade in general anaesthesia plays a significant role in contributing to the above mentioned complications in these patients.Peak expiratory flow rate (PEFR) measurement is a useful and effective bed side tool to assess the severity of airflow limitation in Chronic obstructive pulmonary disease (COPD) patients.Traditionally, reversing residual neuromuscular blockade was achieved with the use of anticholinesterases like neostigmine which had some muscarinic side effects apart from being non selective. Now a days selective neuromuscular reversal agents like Sugammadex have been safely implicated in patients with comorbidities and with low side effects.
The proposed study would aim to compare the efficacy of Sugammadex and Neostigmine using PEFR measurements in preventing post operative pulmonary complications in COPD patients.
The present study is a prospective , single centered , double blinded study in patients undergoing elective laparoscopic abdominal surgeries of various specialities in Bhaarath medical college and hospital . The study would be carried out for 6 months duration.
The primary outcome of the study would be to measure the PEFR in both the groups in the preoperative period and at varied time intervals post operatively.
Any incidence of post operative pulmonary complications(PPC) like COPD exacerbation, inability to clear secretions, bronchospasm and respiratory failure in both the groups measured upto 3 days after the surgery would be chosen as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI 18-25kg/m2 , Patients scheduled for elective laparoscopic abdominal surgeries.
排除标准
- •History of allergy to the study drugs , Chronic renal disease patients ( creatinine clearance lesser than 30ml/min) , Patients with other co existing pulmonary diseases, Patients with severe coronary artery insufficiency and other fixed cardiac output states, Emergency surgeries , Moribund patients.
结局指标
主要结局
Measurement of peak expiratory flow rate in both the groups in the preoperative period and at varied time intervals post operatively
时间窗: Baseline peak expiratory flow rate value preoperatively , immediately following extubation , in hours till 6 hours post procedure then at 24 hours interval till post operative day 3
次要结局
- Evaluate the incidence of post operative pulmonary complications(PPC) like COPD exacerbation, inability to clear secretions, bronchospasm and respiratory failure in both the groups measured upto 3 days after the surgery(Immediately following extubation , in hours till 6 hours post procedure then at 24 hours interval till post operative day 3)
研究者
S Sevukar Raja
Bhaarath Medical College and Hospital