跳至主要内容
临床试验/NCT06796777
NCT06796777尚未招募不适用

Residual Paralysis in the Post Anesthesia Care Unit: the Association Beetween Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio. a Prospective Single-Center Open-Label Cohort Study

Assiut University0 个研究点目标入组 91 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
91
主要终点
the incidence of residual neuromascular block

研究概览

简要总结

The reported incidence of rNMB varies between 16% to more than 70 depending on the used definition (train-of-four [TOF] ratio 0.7 or 0.9), type of NMBA, type of reversal agent, and timing of measurements The degree of residual paralysis can be evaluated in different ways: clinical tests requiring the patients cooperation, which normally can be performed only after emergence; visual or tactile evaluation of responses to TOF or double-burst stimulation (DBS) at the adductor pollicis (qualitative or subjective assessment); and measurement of the TOF ratio (TOFr) with a device (quantitative or objective measurement), For several years, the standard criterion for adequate neuromuscular function recovery was a TOF ratio of 0.7 Residual paralysis risk prediction score (REPS) has been recently invented to identify surgical patients who might be at an increased risk for the development of rNMB. Ten independent predictors for residual paralysis were identified and used for the score development.

Recent literature reported that REPS ≥4 is significantly associated with an increased risk of postoperative respiratory complications when neuromuscular monitoring is not used Does of reverse is neostigmine(.04-.08)mg/kg and does of Atropine .01mg /kg Time of surgical intervention not affecte measurement of residual paralysis in PACU the aim of the study evaluate the degree of association, and the predictive accuracy of the REPS (as a predictive tool) compared with the TOFr as a quantitative assessment tool for (rNMB) in surgical patients in the early postoperative phase. The TOFr will be measured at 0, 15, 30, 45, and 60 min after extubation.

详细描述

The reported incidence of rNMB varies between 16% to more than 70 depending on the used definition (train-of-four [TOF] ratio 0.7 or 0.9), type of NMBA, type of reversal agent, and timing of measurements The degree of residual paralysis can be evaluated in different ways: clinical tests requiring the patients cooperation, which normally can be performed only after emergence; visual or tactile evaluation of responses to TOF or double-burst stimulation (DBS) at the adductor pollicis (qualitative or subjective assessment); and measurement of the TOF ratio (TOFr) with a device (quantitative or objective measurement), For several years, the standard criterion for adequate neuromuscular function recovery was a TOF ratio of 0.7 Residual paralysis risk prediction score (REPS) has been recently invented to identify surgical patients who might be at an increased risk for the development of rNMB. Ten independent predictors for residual paralysis were identified and used for the score development.

Recent literature reported that REPS ≥4 is significantly associated with an increased risk of postoperative respiratory complications when neuromuscular monitoring is not used Does of reverse is neostigmine(.04-.08)mg/kg and does of Atropine .01mg /kg Time of surgical intervention not affecte measurement of residual paralysis in PACU the aim of the study evaluate the degree of association, and the predictive accuracy of the REPS (as a predictive tool) compared with the TOFr as a quantitative assessment tool for (rNMB) in surgical patients in the early postoperative phase. The TOFr will be measured at 0, 15, 30, 45, and 60 min after extubation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1- Age group 18-65 years old 2- Both genders 3- Patients who will be scheduled to undergo elective surgical procedures requiring the use of neuromuscular blocking drugs.
  • 5- Patients with American Society of Anesthesiologist physical status classification of 1 or 2.

排除标准

  • 1- Patients who are less than 18 years old or more than 65 years old. 2- Patients with planned scheduled recovery in the intensive care unit or if more than 10 minutes had elapsed since tracheal extubation until NMB monitoring at the PACU.
  • 3- Patients on medications that interfere with muscle activity. 4- Known allergy to neuromuscular blocking agents. 5- Pregnancy or suspected pregnancy. 6- Neuro-muscular diseases. 7- Patients refusing to participate in the study

结局指标

主要结局

the incidence of residual neuromascular block

时间窗: 60 minutes

the incidence of rNMB assessed by train-of-four ratio at admission to the PACU and at 15, 30, 45, and 60 min after PACU admission to be correlated with the Risk Prediction Score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hossam Mostafa kamel Mohamed

residant doctor

Assiut University

相似试验