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Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery

Primary Purpose

Neuromuscular Blockade, Postoperative Complications

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Succinylcholine
Cisatracurium
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neuromuscular Blockade focused on measuring Postoperative Pulmonary Complications, Residual Neuromuscular Blockade, Cardiac Surgical Procedures

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group CIS

Group SUX

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Number of Participants With Postoperative Pulmonary Complications
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

Surgical Conditions
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

Full Information

First Posted
December 15, 2015
Last Updated
June 19, 2018
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02635542
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade, Postoperative Complications
Keywords
Postoperative Pulmonary Complications, Residual Neuromuscular Blockade, Cardiac Surgical Procedures

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Open label drug administration. Outcomes assessor and care providers are otherwise masked.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group CIS
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group SUX
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Succinylcholine
Other Intervention Name(s)
Suxamethonium
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisatracurium
Other Intervention Name(s)
Nimbex
Intervention Description
Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Pulmonary Complications
Description
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.
Time Frame
72 hours following surgical procedure
Secondary Outcome Measure Information:
Title
Surgical Conditions
Description
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
Time Frame
During general anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca M Gerlach, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery

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