跳至主要内容
临床试验/CTRI/2024/12/078219
CTRI/2024/12/078219尚未招募Phase 3 4

COMPARISON OF REVERSIBILITY OF SUGAMMADEX AND NEOSTIGMINE TO VECURONIUM USED AS MUSCLE RELAXANT UNDER GENERAL ANAESTHESIA

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年1月1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
68
试验地点
1
主要终点
recovery from general anaesthesia after administration of reversal

研究概览

简要总结

Sugammadex is a modified γ-cyclodextrin designed to reverse the effects of the steroidal neuromuscular blocking agents (NMBAs) rocuronium and vecuronium by encapsulation with no effect on cholinergic transmission.In contrast to neostigmine, sugammadex rapidly and effectively re- verses moderate and deep levels of  vecuronium-in- duced neuromuscular blockade (NMB) , and is also effective for immediate reversal of blockade. We wanted to compare between reversibility of sugammadex and neostigmine in prolonged surgeries . Aim is to compare the efficacy of sugammadex with neostigmine for reversal of the effects of  vecuronium as muscle relaxant. Objective is to

compare the reversibility of neostigmine with sugammadex using TOF

To compare :

  1. Time required for complete reversal .

  2. Any residual paralysis / block with standard doses and requirement of added doses.

  3. Side effect if any in post operative period (muscle pain , recurarization / apnea).

This study includes patients classified Under American Society of Anaesthesiologists Physical status I,II&III planned for surgery under general anesthesia.

Group A will receive neostigmine 0.05 mg/ kg . If TOF not till T4 then dose converted to 1 mg/ kg.

Group B will receive sugammadex 2mg/ kg. If in deeper plain of anaesthesia then 4 mg/ kg.

The onset, duration and side effects of post operative analgesia will be recorded and compared

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

  • age 18 to 65 years ASA grade 1 ASA grade 2 ASA grade 3 patient willing to participate in study prolonged duration surgery under general anaesthesia more than 4 hours.

排除标准

  • lack of valid informed consent ASA grade 4 patient with bleeding disorder patient on medication known to interact with neuromuscular blocking drugs.

结局指标

主要结局

recovery from general anaesthesia after administration of reversal

时间窗: Administration of reversal to 24 hours

次要结局

  • time required for complete reversal using TOF

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Payodhi Modi

Datta Meghe Institute of Higher Eduacation and Research

研究点 (1)

Loading locations...

相似试验