NCT02635542

Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromuscular Blockade
• Postoperative Complications

Interventions

Type	Name	Description
DRUG	Succinylcholine	Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
DRUG	Cisatracurium	Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-09-15
• Completion: 2017-09-15
• First posted: 2015-12-21
• Last updated: 2018-07-17
• Results posted: 2018-07-17

Locations

1 site across 1 country: United States