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临床试验/CTRI/2026/03/106125
CTRI/2026/03/106125尚未招募不适用

EFFICACY OF SUGAMMADEX VERSUS NEOSTIGMINE FOR REVERSAL OF ROCURONIUM-INDUCED NEUROMUSCULAR BLOCKADE IN ADULTS UNDERGOING ELECTIVE SURGERY: A RANDOMISED CONTROLLED STUDY

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2028年3月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1

研究概览

简要总结

Reversal of neuromuscular blockade (NMB) is essential for optimal recovery following general anaesthesia. Neostigmine has long served as the conventional agent for this purpose; however, sugammadex a novel cyclodextrin compound specifically engineered to counteract rocuronium-induced NMB has demonstrated promising advantages in terms of speed and reliability. Although both agents facilitate reversal of rocuronium, their comparative efficacy and safety profiles remain subjects of ongoing clinical scrutiny, particularly when assessed using train-of-four (TOF) neuromuscular monitoring.

This  randomized controlled trial is designed to evaluate the efficacy of sugammadex versus neostigmine for reversing  rocuronium-induced NMB in adult patients undergoing elective surgical procedures under general anaesthesia. TOF monitoring will be employed to ensure objective and quantifiable assessment of efficacy of neuromuscular recovery as determined by the time to achieve the primary outcome.

A total of 100 adult patients who meet eligibility criteria and provide informed consent will be enrolled. The primary outcome is the time required to achieve a TOF ratio (TOFR) of  gretaer than  0.9 after administration of reversal agent. Secondary outcomes include the incidence of adverse respiratory events in the post-anaesthesia care unit (PACU) till 60 minutes after extubation, as well as perioperative changes in hemodynamic parameters, namely, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP).

While international literature consistently supports the superior efficacy of sugammadex over neostigmine in reversing rocuronium-induced NMB,  to the best of our knowledge, there is no study in the Indian population. To address this gap, our study seeks to generate contextually relevant evidence.

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I and II Duration of surgery is less than 2 hours.

排除标准

  • Patients refusing to participate in the study Patients with known neuromuscular disorders Patients undergoing organ transplant surgery emergency procedures and patients needing intensive care admission in the postoperative period Obese patients with a body mass index BMI greater than 30kg/m2 Renal or hepatic dysfunction Women taking oral contraceptives Pregnant patients Allergy to drugs under study.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Abhjit Singh Pahwa

Institute of Anaesthesiology, Pain and Perioperative Medicin

研究点 (1)

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