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临床试验/NCT03111082
NCT03111082已完成不适用

Incidence of Postoperative Neuromuscular Blockade in the Post-Anesthesia Care Unit at Parkland Hospital: Does Size Matter?

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Incidence of Residual Neuromuscular Blockade

研究概览

简要总结

This prospective, observational study will assess 100 subjects in the post-anesthesia care unit (PACU) at Parkland Hospital. Upon arrival to the PACU, patients' train-of-four (TOF) ratio will be calculated using the StimPod NMS450 accelerometer to determine the presence of any residual paralysis. Any patient with a TOF ratio < 0.9 will be reassessed every 10 minutes until the ratio is ≥0.90. The time it takes to reach a TOF ratio ≥0.9 will be recorded. Subjects will be classified according to BMI categories: lean as <30 kg/m2, obese as 30≤BMI≤39.9 kg/m2, and morbidly obese as BMI ≥40 kg/m2. This data will serve as a baseline to assess the incidence of residual NMB that currently occurs in our PACU so that we may use this pilot data to design future studies that aim to reduce the incidence of residual NMB.

详细描述

Upon arrival to the PACU, patients enrolled in the study will be evaluated for residual paralysis with train-of-four (TOF) stimulation using the StimPod NMS450 accelerometer set to 30 mA. Any patients who have residual paralysis will be assessed Q10 minutes until the TOF ratio is ≥0.9. The time to achieve a TOF ratio ≥0.9 will be recorded. Any adverse events (e.g., hypoxia, reintubation, aspiration) that arise during the patient's PACU stay will be documented.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 years old
  • Undergoing non-emergent surgery with general endotracheal anesthesia
  • ASA physical status classification 1 to 4
  • Willing and able to consent in English or Spanish
  • No personal history of neuromuscular disease

排除标准

  • Age less than 18 or older than 80
  • Patient does not speak English or Spanish
  • Planned postoperative intubation or ICU admission
  • Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
  • Family or personal history of malignant hyperthermia
  • Patient refusal
  • Monitored anesthesia care (MAC) or regional anesthesia planned
  • Pregnant or nursing women
  • "Stat" (emergent) cases
  • Estimated creatinine clearance <30 mL/min
  • Pre-existing muscle weakness of any etiology

结局指标

主要结局

Incidence of Residual Neuromuscular Blockade

时间窗: 1 day on arrival to PACU

To establish the current incidence of postoperative residual neuromuscular blockade (NMB), defined as a train-of-four ratio \<0.9, in patients upon arrival to the PACU.

次要结局

  • Comparison of RNMB in Lean, Obese, and Morbidly Obese Patients(1 day on arrival to PACU)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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