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临床试验/CTRI/2024/05/068057
CTRI/2024/05/068057尚未招募Phase 3 4

A Comparative Study of Sugammadex versus Neostigmine for Reversal of Vecuronium-Induced Neuromuscular Blockade Following Intracranial Tumor Resection Surgery In Adults

Jawaharlal Nehru Medical CollegeDatta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Time taken for the reversal of neuromuscular blockade

研究概览

简要总结

Introduction:Intracranial surgeries demand precise neuromuscular control to ensure optimal conditions and minimize patient movement. Traditional reversal agents like Neostigmine may have limitations, prompting the investigation of Sugammadex, which offers rapid and specific reversal of neuromuscular blockade induced by agents like Vecuronium.Objective: This study aims to compare the efficacy, safety, and speed of recovery between Sugammadex and Neostigmine in reversing Vecuronium-induced neuromuscular blockade following intracranial surgery.Methods: A prospective, randomized controlled trial will be conducted on adults undergoing intracranial tumor resection surgery. Patients will be randomly allocated to receive either Sugammadex (2mg/kg) or Neostigmine (0.05mg/kg) for neuromuscular blockade reversal. Various parameters including time to reversal, incidence of residual blockade, recovery of neuromuscular function, and safety outcomes will be assessed.Results: A total of 50 patients will be included, with 25 in each group. Primary outcomes include time taken for reversal of neuromuscular blockade, while secondary outcomes encompass residual blockade incidence, neuromuscular function recovery, and safety profiles.Conclusion: This study will provide valuable insights into the comparative efficacy and safety of Sugammadex and Neostigmine in reversing Vecuronium-induced neuromuscular blockade following intracranial surgery. Findings will contribute to optimizing anesthesia practices, enhancing patient outcomes, and minimizing postoperative complications in this critical surgical setting.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria:
  • Consenting adults, undergoing elective intracranial tumor surgery under general anaesthesia with Vecuronium-induced neuromuscular blockade.
  • 2.Adult patient above age of 18yrs -65yrs 3.No comorbidity 4.GCS –15/15.

排除标准

  • 1.Patients with contraindications to Sugammadex or Neostigmine 2.Pre-existing neuromuscular disorders
  • Those requiring prolonged postoperative ventilation.
  • 4.Malignant hyperthermia.

结局指标

主要结局

Time taken for the reversal of neuromuscular blockade

时间窗: 1 hour

次要结局

  • 2. Incidence of residual neuromuscular blockade post-reversal.(3. Recovery of neuromuscular function assessed via train-of-four ratio or similar monitoring methods.)

研究者

发起方
Jawaharlal Nehru Medical CollegeDatta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Aishwarya Nayak

Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research,Sawangi

研究点 (1)

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