跳至主要内容
临床试验/CTRI/2024/09/074341
CTRI/2024/09/074341尚未招募不适用

Incidence of Residual Neuromuscular Blockade in the Postanaesthesia Care Unit: An Observational Study.

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2024年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
288
试验地点
1
主要终点
Patients having neuromuscular blockade TOF ratio less than 0.9.

研究概览

简要总结

Residual neuromuscular blockade is a known cause of postoperative complications

after general anaesthesia with relaxants. Various reasons have been cited for this, including

but not limited to the type of surgery, duration of surgery, neuromuscular blocker used, dose

of Neuromuscular blockade and the type and dose of reversal used. Many measures have

been suggested to reduce the incidence of Residual neuromuscular blockade, like adequate

titration of dose of Neuromuscular blockade and reversal used and timing of the reversal

agent, to preclude Residual neuromuscular blockade but various studies continue to show

significant incidence of Residual Neuromuscular blockade and its associated morbidity.

Neuromuscular monitoring is a useful tool, both intraoperatively and postoperatively to guide

Neuromuscular blockade use and reversal but is not used often and to its potential. It can

significantly reduce the incidences of Residual neuromuscular blockade.

We aim to conduct an observational study into the incidence of Residual

neuromuscular blockade in the post anaesthesia care unit of patients undergoing surgery in

general anaesthesia with muscle relaxants. This study will include 290 Patients. All patients

found eligible and who consent to the study will be enrolled. Demographic and clinical

details of the patients will be noted. All patients undergoing surgery under general

anaesthesia, will be checked for Residual neuromuscular blockade with a neuromuscular

monitor using Train of four mode, on their arrival to the Post anaesthesia care unit. Patients

having a TOF ratio < 0.9 will be considered to have a Residual neuromuscular blockade.

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

  • ASA physical classification I to II
  • Patients undergoing lower abdominal surgery, general, urological, or gynaecologic surgery under general anaesthesia with neuromuscular blockade.

排除标准

  • Patients not consenting.
  • Patients with known neuromuscular disorders (e.g. myasthenia gravis)
  • Patients undergoing organ transplant surgery, open upper abdominal surgery, emergency procedures, and patients needing intensive care admission in the post-operative period.
  • Patient undergoing thoracic surgery.

结局指标

主要结局

Patients having neuromuscular blockade TOF ratio less than 0.9.

时间窗: 10 mins after extubation

次要结局

  • a. Fall of SpO2 less than 95 % on oxygen support.(b. Duration of stay in PACU.)

研究者

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

Dr Savitar Malhotra

Institute of Anaesthesiology Pain and Perioperative Medicine

研究点 (1)

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