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临床试验/NCT02635542
NCT02635542已完成4 期

Prospective, Randomized Trial Comparing Effect of General Anesthesia With and Without Neuromuscular Blockade on Postoperative Pulmonary Complications in Elective Cardiac Surgical Patients

University of Chicago1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of Participants With Postoperative Pulmonary Complications

研究概览

简要总结

The investigators will conduct a prospective, randomized trial to assess the impact of neuromuscular blockade on early (<72 hours post-ICU admission) postoperative respiratory complications in cardiac surgical patients. The study will compare continual neuromuscular blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for cardiac surgery.

详细描述

Residual neuromuscular blockade during the immediate postoperative period is an important patient safety issue. Although used to facilitate the technical performance of surgery, clinical studies have associated neuromuscular blockade (NMB) with increased incidence of postoperative respiratory complications. This effect is likely mediated by residual neuromuscular blockade interfering with airway tone and respiratory effort, leading to postoperative pneumonia, atelectasis or aspiration. However, the vast majority of these studies have involved non-cardiac patient populations, yet patients undergoing cardiac surgery are even more susceptible to the detrimental effects of residual neuromuscular blockade for a number of reasons. Despite widespread utilization of paralysis during cardiac surgery, very little is known about residual neuromuscular blockade in patients following cardiac surgery. Previously published clinical studies date from over a decade ago or are based on retrospective databases from non-cardiac surgery patients, precluding generalizable conclusions. Given the substantial role of neuromuscular blockade in the traditional management of cardiac surgical patients, prospective data is needed to determine the veracity of this association as well as the surgical tolerability of protocols that minimize intraoperative paralysis. The investigators will conduct a prospective, randomized trial to assess impact of neuromuscular blockade on early (<72 hours post-ICU admission) postoperative 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
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Open label drug administration. Outcomes assessor and care providers are otherwise masked.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective cardiac surgery (CABG, valve replacement, CABG + valve) requiring cardiopulmonary bypass

排除标准

  • Emergency surgery
  • Extremes of age
  • Previous cardiac surgery
  • Clinical contraindications to succinylcholine or cisatracurium
  • Anticipated difficult tracheal intubation
  • Preoperative mechanical ventilation
  • Preoperative pharmacologic/mechanical hemodynamic support

研究组 & 干预措施

Group CIS

Active Comparator

Continual neuromuscular blockade (standard therapy) during general anesthesia will be provided with cisatracurium (CIS), with 0.2mg/kg IV given as an initial dose and repeated dosing determined by neuromuscular blockade monitoring (peripheral nerve stimulator maintained at 1-2 twitches).

干预措施: Cisatracurium (Drug)

Group SUX

Experimental

A single dose of neuromuscular blockade (experimental group) will be provided at the start of anesthesia with succinylcholine (SUX), with 1mg/kg IV given as an initial dose and no repeat dosing.

干预措施: Succinylcholine (Drug)

结局指标

主要结局

Number of Participants With Postoperative Pulmonary Complications

时间窗: 72 hours following surgical procedure

Having at least one of the following complications, determined according to pre-specified criteria: extubation delayed \>24hrs, reintubation, mechanical respiratory support, pneumonia, aspiration, ARDS (Acute Respiratory Distress Syndrome), or mortality from respiratory arrest.

次要结局

  • Surgical Conditions(During general anesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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