Comparison between sugammadex and neostigmine in terms of postoperative respiratory muscle strength recovery in obese patients undergoing laparoscopic gynaecological surgery. A randomized controlled trial.
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
- To assess the recovery of respiratory muscle strength using
研究概览
简要总结
The incidence of postoperative residual curarization (PORC) has been reported to be as high as 45.2% in the post-anesthesia care unit. Adequate reversal of neuro muscular blockade is important to regain muscle strength in the post operative period. PORC can result in many adverse effects such
as post operative hypoxemia, atelectasis and increased pulmonary complications. Sugammadex is proposed to provide better muscle reversal, however whether this translates into better muscle strength has not been evaluated well. Better post operative recovery of muscle strength could prevent
post operative pulmonary complications (PPC). In a retrospective cohort matched, observational study, such complications were reported to be 30–50% lower after administration of sugammadex. This study will compare recovery of muscle strength after giving both the drugs. We will and also
assess to what extent post-operative atelectasis depends upon muscle strength recovery in the post-operative period. We hypothesise that the lung ultrasound findings in the post operative period are likely to be better when Sugammadex is given and the improved muscle recovery with sugammadex
could prevent atelectasis and postoperative pulmonary complications better
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients aged 18 to 60 years with BMI greater than 30kg/m2 undergoing laparoscopic gynaecological surgeries.
排除标准
- •Significant kidney disease (stage 4 kidney disease or higher).
- •2.Significant liver disease (Child Pugh B or C class)
- •Allergic to neostigmine or sugammadex.
- •Any history of a neuromuscular disorder.
- •History of chronic obstructive pulmonary disease.
- •6.Pregnancy or nursing women.
结局指标
主要结局
To assess the recovery of respiratory muscle strength using
时间窗: calculated at 30 minutes and 120 minutes after | giving reversal agent and compare with baseline | values
thickening fraction of internal oblique
时间窗: calculated at 30 minutes and 120 minutes after | giving reversal agent and compare with baseline | values
次要结局
- To assess the post operative atelectasis by the(modified LUS score based on lung ultrasound.)
研究者
Anakha S
AIIMS PATNA