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临床试验/NCT06386354
NCT06386354招募中不适用

Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications

Dr. Negrin University Hospital2 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
296
试验地点
2
主要终点
Residual Neuromuscular Block

研究概览

简要总结

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient.

详细描述

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. In this prospective observational study, all patients who underwent general anesthesia with neuromuscular blockade were studied consecutively to evaluate the presence of residual neuromuscular blockade and its potential consequences during hospital admission.Considering that the percentage of residual curarization is 19% (PORCzero study), with a 95% confidence interval and a 3% error margin, 236 patients are needed to accurately estimate the prevalence of residual curarization in the study population. With an expected loss proportion of 20%, the chosen sample size is 296 patients.

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

  • Patient undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time and that required hospital admission.
  • Informed consent signature.

排除标准

  • Neuromuscular disease
  • Not having received neuromuscular block during the intervention
  • Admission to the outpatient surgery unit
  • Admission to the postoperative intensive care unit
  • Patients who signed informed consent, but postoperative data could not be collected upon arrival at the PACU.

结局指标

主要结局

Residual Neuromuscular Block

时间窗: 8 minutes postoperatively

Train-Of-Four ratio 3 minutes after the arrival to the Post-Anesthetic Care Unit

次要结局

  • Postoperative complications(30 days postoperatively)

研究者

发起方
Dr. Negrin University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ángel Becerra-Bolaños, MD PhD

PhD

Dr. Negrin University Hospital

研究点 (2)

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