Clinical trial NCT02635542: Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery
Official title: Prospective, Randomized Trial Comparing Effect of General Anesthesia With and Without Neuromuscular Blockade on Postoperative Pulmonary Complications in Elective Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Postoperative Complications
Keywords: Postoperative Pulmonary Complications
Residual Neuromuscular Blockade
Cardiac Surgical Procedures
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Postoperative Pulmonary Complications
timeFrame: 72 hours following surgical procedure
Secondary outcomes:
measure: Surgical Conditions
timeFrame: During general anesthesia
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Rebecca M Gerlach, MD
role: PRINCIPAL_INVESTIGATOR
References: