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临床试验/NCT03574337
NCT03574337撤回4 期

Residual Neuromuscular Blockade in Cardiac Surgery Patients

Henry Ford Health System1 个研究点 分布在 1 个国家开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Time from arrival in CVICU until extubation

研究概览

简要总结

The purpose of this project is to determine if reversal of neuromuscular blockade in cardiac surgery patients expedites time to extubation in fast track patients.

详细描述

Neuromuscular blocking agents are used as part of most general anesthetics to help facilitate tracheal intubation and optimal surgical conditions (Barish et al). These medications cause universal paralysis of patients while unconscious. After most surgeries where extubation is planned, the standard of care is to "reverse" any residual neuromuscular blockade with either anticholinesterase treatment (specifically neostigmine) or sugammadex. Despite adequate reversal, residual neuromuscular blockade is a common problem seen in the post-anesthetic care unit (PACU). It leads to issues of airway obstruction, hypoxemia, respiratory complications including atelectasis and pneumonia and muscle weakness (Brull et al). The investigators posit that these complications are likely amplified in patients who require post-operative intensive care unit admission. In particular, the investigators hypothesize that cardiac surgery patients are at risk. Elective cardiac surgery patients are routinely admitted to the CVICU still intubated and ventilator-dependent immediately following surgery. The goal of uncomplicated cardiac surgery patients (fast track cardiac surgery patients) is to extubate them within 6 hours of ICU arrival. However, standard of care throughout the US does not include reversal of their neuromuscular blockade. By the time these patients meet extubation criteria, most providers believe that the neuromuscular blockade should have worn off and therefore do not administer reversal (Murphy et al). The investigators hypothesize that residual neuromuscular blockade delays time to extubation and increases respiratory complications in fast track cardiac surgery patients. By administering reversal of neuromuscular blockade in patients with a Train Of Four ratio of <0.9 we anticipate that there will be an increase from 60 to 85% of patients being successfully extubated within 6 hours of arrival to the ICU and a decrease in composite respiratory complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • All outpatients >18 years of age scheduled for elective coronary artery bypass graft surgery (CABG), aortic valve replacement (AVR), or combination CABG/AVR

排除标准

  • Chronic kidney disease stage IV or V
  • Liver disease, defined as AST, ALT or ALP > 1.5x upper limit of normal Inpatient status
  • Allergy to rocuronium

研究组 & 干预措施

Sugammadex

Active Comparator

Patient's will receive sugammadex at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight and TOF ratio by the pharmacy. It will be a one time dose at the end of the case

干预措施: Sugammadex (Drug)

Neostigmine/glycopyrrolate

Active Comparator

Patient's will receive neostigmine/glycopyrrolate at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight (50mcg/kg of neostigmine with an equivalent volume to volume ratio of glycopyrrolate). It will be a one time dose at the end of the case

干预措施: neostigmine/glycopyrolate (Drug)

结局指标

主要结局

Time from arrival in CVICU until extubation

时间窗: through study completion, an average of 1 year

次要结局

  • Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula(through study completion, an average of 1 year)
  • Tidal volumes prior to extubation(Prior to extubation, the tidal volumes the patient is generating will be documented)
  • Pneumonia(through study completion, an average of 1 year)
  • Number of participants requiring re-intubation(through study completion, an average of 1 year)
  • Bronchoscopy(through study completion, an average of 1 year)
  • Intensive care unit length of stay(through study completion, an average of 1 year)
  • Mortality(28 days following the surgery)
  • Lowest documented pulse oximetry(through study completion, an average of 1 year)

研究者

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

Mary Jarzebowski

Anesthesiologist

Henry Ford Health System

研究点 (1)

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