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Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02635542
Recruitment Status : Completed
First Posted : December 21, 2015
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Postoperative Complications Drug: Succinylcholine Drug: Cisatracurium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Open label drug administration. Outcomes assessor and care providers are otherwise masked.
Primary Purpose: Prevention
Official Title: Prospective, Randomized Trial Comparing Effect of General Anesthesia With and Without Neuromuscular Blockade on Postoperative Pulmonary Complications in Elective Cardiac Surgical Patients
Actual Study Start Date : March 2016
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group CIS
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).
Drug: Cisatracurium
Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
Other Name: Nimbex

Experimental: Group SUX
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.
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.
Other Name: Suxamethonium




Primary Outcome Measures :
  1. Number of Participants With Postoperative Pulmonary Complications [ Time Frame: 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.


Secondary Outcome Measures :
  1. Surgical Conditions [ Time Frame: During general anesthesia ]
    Assessed by surgeon questionnaire designed for study to determine any negative effects impeding the progress of surgery or safety, on scale of 1=poor to 5=excellent



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635542


Locations
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United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Rebecca M Gerlach, MD University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02635542     History of Changes
Other Study ID Numbers: 15-1016
First Posted: December 21, 2015    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018
Last Verified: June 2018
Keywords provided by University of Chicago:
Postoperative Pulmonary Complications
Residual Neuromuscular Blockade
Cardiac Surgical Procedures
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Anesthetics
Cisatracurium
Succinylcholine
Central Nervous System Depressants
Physiological Effects of Drugs
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Neuromuscular Depolarizing Agents