Comparison of Neuromuscular reversal with Neostigmine and Glycopyrrolate verses Sugammadex on bowel motility recovery after Laparoscopic colorectal surgery.A prospective Randomised study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Return of Bowel motility 24 hour postoperatively.
研究概览
简要总结
This prospective randomised study aims to evaluate the effect of neuromuscular blockade reversal using Neostigmine with Glycopyrrolate verses Sugammadex on postoperative bowel motility recovery in patients undergoing laparoscopic colorectal surgery. Delayed return of bowel motility is common postoperative complication and cause prolong hospital stay. While Neostigmine -Glycopyrrolate combination slows bowel recovery due to anticholinergic side effects, Sugammadex offers a novel mechanism of action lead to faster bowel motility recovery. The primary outcome is first postoperative bowel movement assessed by first flatus or stool passage. This study is based on the fact that Sugammadex leads to earlier bowel motility recovery compared to Neostigmine-Glycopyrrolate combination due to its unique mechanism of action and lack of anticholinergic side effects that facilitates enhanced recovery, reducing postoperative complications and reduce hospital stay.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients with ASA physical status I, II, or III.
- •2 Patients aged 18 years and above of either sex undergoing laparoscopic colorectal surgery.
- •3 Patients able to comprehend and willing to participate.
- •4 Patients scheduled for neuromuscular blockade reversal with either Neostigmine-glycopyrrolate or Sugammadex.
排除标准
- •1 Patients who refuse to participate.
- •2 Patients with known hypersensitivity to neostigmine, glycopyrrolate, or sugammadex.
- •3 Patients with severe renal or hepatic dysfunction.
- •4 Patients with pre-existing bowel motility disorders.
- •5 Patients with significant cognitive impairment.
结局指标
主要结局
Return of Bowel motility 24 hour postoperatively.
时间窗: Return of Bowel motility 24 hour postoperatively.
次要结局
- Time to first oral intake.(Evaluate postoperative nausea and vomiting.)
研究者
Priyanka Kumari
Indira Gandhi Institute of Medical Sciences,Patna.