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临床试验/CTRI/2025/08/092592
CTRI/2025/08/092592已完成不适用

Effect Of Rocuronium- Sugammadex Versus Atracurium - Neostigmine On Time To Extubation: A Randomized Parallel Group Study

All India Institute of Medical Sciences Bibinagar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月24日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Time to tracheal extubation from application of surgical dressing, in minutes.

研究概览

简要总结

Introduction:Efficient anaesthesia reversal is essential for optimizing operating room (OR) time and patient outcomes. Rocuronium (reversed by sugammadex) and atracurium (reversed by neostigmine) are commonly used. Sugammadex offers faster reversal but is costly and often unavailable in resource-limited settings. Current studies focus on time from reversal agent administration, not from surgical completion, missing critical OR time delays. This study addresses that gap by comparing time to extubation from end of surgery, evaluating clinical outcomes and cost-effectiveness, particularly in the Indian healthcare context. Objectives:Primary Objective: Compare time from surgical dressing to extubation between Rocuronium-Sugammadex (RS) and Atracurium-Neostigmine (AN) groups. Secondary Objectives: Time from extubation to OR exit Incidence of postoperative adverse events (within 24 hours) Rationale & Novelty:Sugammadex is new in India; its cost and lack of monitoring tools limit usage. Previous studies measured reversal time from drug administration, not surgical end. No Indian studies use clinical criteria for reversal timing. The study offers a real-world, clinically relevant evaluation that may influence practice and cost management. Hypothesis:Rocuronium-sugammadex leads to a shorter time to extubation from end of surgery compared to atracurium-neostigmine. Methodology:Design: Randomized parallel group study Duration: 12 months (8 months data collection, 2 months analysis & writing) Population: 60 adult patients (30 per group), aged 19–60, ASA I–II, undergoing elective surgery under GA lasting 30 min–3 hrs Randomization: 1:1 allocation Intervention: Group AN: Atracurium + Neostigmine-Glycopyrrolate (on spontaneous effort) Group RS: Rocuronium + Sugammadex (immediately after dressing; repeated every 3 mins up to 16 mg/kg as needed) Extubation Criteria: Awake, responsive, stable vitals, adequate spontaneous breathing Post-op Monitoring: 24 hours for complications (desaturation, obstruction, re-intubation) Sample Size:Although minimum of 4 patients (2 per group) was statistically sufficient, 30 per group were recruited to improve generalizability and allow robust analysis. Expected Outcome:Faster extubation in the RS group could justify the higher drug cost by saving OR time, improving efficiency, reducing staff stress, and optimizing resource use — especially relevant for developing healthcare systems.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2 patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation.
  • Estimated duration of surgery being 30 minutes to 3 hours.

排除标准

  • Patient refusal.
  • Requirement of post-operative mechanical ventilation.
  • Anticipated difficult airway.
  • Pregnant patients.
  • Patients planned for extubation under deep planes of anesthesia.

结局指标

主要结局

Time to tracheal extubation from application of surgical dressing, in minutes.

时间窗: Time period measured between application of surgical dressing and removal of endotracheal tube after patient meets extubation criteria.

次要结局

  • Time to patient shift out of operating room from tracheal extubation.(Time period measured between tracheal extubation and patient leaving the operating room to the post-anaesthesia care unit.)
  • Adverse events, if any(up to twenty four hours after extubation.)

研究者

发起方
All India Institute of Medical Sciences Bibinagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ayya Syama Sundar

All India Institute of Medical Sciences, Bibinagar

研究点 (1)

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