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临床试验/CTRI/2025/09/094502
CTRI/2025/09/094502尚未招募2 期

Comparison of effects of sugammadex in recommended dose and fixed dose on reversal of moderate neuromuscular blocking and recovery profile in patients under general anaesthesia.

ESIC Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月23日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare the time taken to achieve a normalized TOF ratio 0.9 between recommended dose and fixed dose of suggamadex in reversing moderate neuromuscular blockade.

研究概览

简要总结

This prospective, double blinded, randomized controlled trial compares the effects and recovery patterns of a fixed dose 200mg of sugammadex versus the recommended 2mg/kg dose for reversing moderate neuromuscular blockade in adults undergoing general anesthesia for elective surgeries expected to last over 120 minutes. The study aims to enroll 40 consented patients who are fulfilling inclusion criteria and assessed for exclusion criteria. Participants will be randomly allocated with the help of computer generated randomisation to either Group R (2mg/kg sugammadex) or Group F (200mg sugammadex), both administered as slow intravenous infusion in 100ml normal saline. Then time taken to achieve a normalized Train-of-Four (TOF) ratio greater than or equal to 0.9 in the two dosing strategies. Simultaneously the time from sugammadex administration to spontaneous respiration, response to verbal commands, adequate motor control, extubation and total recovery time is also measured alongside monitoring and managing adverse events such as bradycardia or anaphylaxis. Comprehensive intraoperative monitoring including ECG, NIBP, SpO2, EtCO2, Temperature, Heart Rate, Neuromuscular Function via TOF and bispectral index will be employed. All the data are recorded every 5 minutes intraoperatively and every 15 seconds after sugammadex administration.

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
19.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.19-55 years of age of both sexes.
  • 2.A BMI 20-30 kg/m
  • 3.Patient belonging to ASA Physical status I and II.
  • 4.Scheduled for elective surgery with expectant duration greater than 120 minutes under general anesthesia with written informed consent.

排除标准

  • 1.Patients with contraindication to sugammadex.
  • 2.Patients who are pregnant.
  • 3.Neuromuscular disorders.

结局指标

主要结局

To compare the time taken to achieve a normalized TOF ratio 0.9 between recommended dose and fixed dose of suggamadex in reversing moderate neuromuscular blockade.

时间窗: Initial point - Administration of sugammadex on day of surgery after completion of surgical procedure. | Final point- Time at which a normalized TOF ratio of 0.9 is achieved on day of surgery after administration of sugammadex.

次要结局

  • To assess time taken from sugammadex administration to fowllowing points (1)spontaneous respiration (2)response to verbal commands (3)motor control (4)extubation (5)recovery time (sugammadex to extubation)
  • To assess advere events & their management in both dosing strategies.(On day of surgery after completion of surgical procedure)

研究者

发起方
ESIC Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

M P Manu Pradeep

ESIC Medical College and Hospital

研究点 (1)

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