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临床试验/CTRI/2025/11/097736
CTRI/2025/11/097736
招募中
不适用

Accuracy of train of four ratio and ultrasound derived diaphragm excursion as an indicator of reversal of neuromuscular blockade

Harman Preet Singh Kalra1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年11月30日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Harman Preet Singh Kalra
入组人数
90
试验地点
1
主要终点
To determine accuracy of train of four ratio and ultrasound derived diaphragm excursion as an indicator of reversal of neuromuscular blockade.

概览

简要总结

General anaesthesia commonly involves the use of neuromuscular blocking drugs, but residual neuromuscular paralysis in the postoperative period remains a significant cause of morbidity and mortality. Traditional qualitative assessments such as sustained head lift and hand grip are unreliable, with studies showing up to 60 percent of patients experiencing postoperative residual curarization . The 2023 ASA guidelines emphasize that clinical assessment alone is insufficient, recommending quantitative monitoring such as the Train-of-Four ratio, with a TOF more than or equal to 0.9 indicating adequate recovery. However, TOF monitoring has limitations, including the need for specialized equipment, baseline calibration, and patient discomfort.

Ultrasound of the diaphragm has recently gained attention as a non-invasive, real-time tool to assess diaphragmatic function through parameters such as diaphragmatic excursion, which reflects contractility and strength. Neostigmine, the most commonly used reversal agent, can variably affect diaphragmatic performance, and inappropriate dosing may paradoxically worsen muscle weakness.

This study aims to evaluate the feasibility and accuracy of ultrasound-derived diaphragmatic excursion as a surrogate marker for assessing neuromuscular recovery compared with the gold-standard TOF ratio. By correlating ultrasound findings with TOF values following neostigmine reversal 0.04 mg per kg. The study seeks to determine whether diaphragmatic ultrasound can serve as a practical, reliable, and less painful alternative for predicting residual neuromuscular blockade and guiding safe extubation, ultimately improving postoperative respiratory outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients posted for elective surgeries under general anaesthesia.
  • 2.ASA grades I and II.

排除标准

  • 1.Surgical procedures performed in critical or urgent situations.
  • 2.Patients with pre existing pulmonary diseases.
  • 3.Patients with phrenic nerve paralysis.
  • 4.Patients with Neuromuscular disorders such as Myasthenia Gravis etc.

结局指标

主要结局

To determine accuracy of train of four ratio and ultrasound derived diaphragm excursion as an indicator of reversal of neuromuscular blockade.

时间窗: The TOF will be calculated at the baseline before induction and before extubation when spontaneous respiration returns. The diaphragm excursion will be measured as the vertical movement of the right hemidiaphragm during quiet spontaneous breathing, before the induction of the patient and before extubation, on return of spontaneous respiration and in the post operative room at different times (15 mins, 30 mins, 45 mins).

次要结局

  • 1.To assess reversal of neuromuscular blockade at the end of surgery by these two methods(2.To determine the prevalence of postoperative respiratory complications (PORC) if any in the immediate postoperative period.)

研究者

发起方
Harman Preet Singh Kalra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr.Jyoti Pathania

Rohilkhand Medical College and Hospital, Bareilly

研究点 (1)

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