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临床试验/CTRI/2024/04/065600
CTRI/2024/04/065600尚未招募4 期

A study comparing recovery characteristics of patients recieving either Sugammadex or Neostigmine and Glycopyrollate, for reversal of rocuronium induced Neuromuscular block

Manipal Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2024年4月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
109
试验地点
1
主要终点
Time taken for complete reversal of neuromuscular block

研究概览

简要总结

In this study we are comparing the recovery characteristics of patients receiving either Sugammadex or Neostigmine and Glycopyrollate for reversal of Rocuronium induced Neuromuscular blockade. We compare the time taken for complete reversal and other complications like change in respiratory function, duration of stay IN PACU, PONV and other complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists grades 1, 2, and 3 patients aged 18–60 years, coming for elective laparoscopic surgeries (lasting one to three hours) will be recruited for the study.

排除标准

  • Patients with cardiorespiratory abnormalities (New York Heart Association heart failure grades 3 and
  • Known allergy to Rocuronium.
  • Renal insufficiency (eGFR<60).
  • Liver dysfunction (liver enzymes—serum glutamic oxaloacetic transaminase/ serum glutamic pyruvic transaminase values elevated by more than 50% of normal).
  • • Underlying neuromuscular disease or the use of drugs known to interfere with neuromuscular transmission.
  • • Intraoperative hypothermia (core temperature less than 35°C).
  • • Known Emphysema.
  • • Unwillingless to perform PFT.

结局指标

主要结局

Time taken for complete reversal of neuromuscular block

时间窗: Reversal given at TOF count of 2 and time taken to reach TOF ratio 0.9. It is checked at the end of each case at the time of extubation.

次要结局

  • To compare post operative respiratory function in terms of PFT(PFT to be done in post anaesthesia care unit 20 minute after extubation)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Sameer Akthar B

Manipal Hospital

研究点 (1)

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