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Residual Neuromuscular Blockade in Cardiac Surgery Patients

Primary Purpose

Residual Neuromuscular Blockade

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sugammadex
neostigmine/glycopyrolate
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Residual Neuromuscular Blockade focused on measuring Residual neuromuscular blockade, Reversal, Cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All outpatients >18 years of age scheduled for elective coronary artery bypass graft surgery (CABG), aortic valve replacement (AVR), or combination CABG/AVR

Exclusion Criteria:

  • Chronic kidney disease stage IV or V
  • Liver disease, defined as AST, ALT or ALP > 1.5x upper limit of normal Inpatient status
  • Allergy to rocuronium

Sites / Locations

  • Henry Ford Health Systems

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Sugammadex

Neostigmine/glycopyrrolate

No reversal administered

Arm Description

Patient's will receive sugammadex at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight and TOF ratio by the pharmacy. It will be a one time dose at the end of the case

Patient's will receive neostigmine/glycopyrrolate at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight (50mcg/kg of neostigmine with an equivalent volume to volume ratio of glycopyrrolate). It will be a one time dose at the end of the case

No reversal administered at the end of the case

Outcomes

Primary Outcome Measures

Time from arrival in CVICU until extubation

Secondary Outcome Measures

Tidal volumes prior to extubation
Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula
Assess how many liters of oxygen the patient requires to maintain pulse oximetry >92%
Lowest documented pulse oximetry
Number of participants requiring re-intubation
If the patient is extubated in the intensive care unit but then develops respiratory failure and requires mechanical ventilation again
Bronchoscopy
Change in baseline oxygen requirements from prior to the surgery
Pneumonia
Change in baseline oxygen requirements from prior to the surgery
Intensive care unit length of stay
Mortality

Full Information

First Posted
May 28, 2018
Last Updated
February 1, 2022
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03574337
Brief Title
Residual Neuromuscular Blockade in Cardiac Surgery Patients
Official Title
Residual Neuromuscular Blockade in Cardiac Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate funding
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this project is to determine if reversal of neuromuscular blockade in cardiac surgery patients expedites time to extubation in fast track patients.
Detailed Description
Neuromuscular blocking agents are used as part of most general anesthetics to help facilitate tracheal intubation and optimal surgical conditions (Barish et al). These medications cause universal paralysis of patients while unconscious. After most surgeries where extubation is planned, the standard of care is to "reverse" any residual neuromuscular blockade with either anticholinesterase treatment (specifically neostigmine) or sugammadex. Despite adequate reversal, residual neuromuscular blockade is a common problem seen in the post-anesthetic care unit (PACU). It leads to issues of airway obstruction, hypoxemia, respiratory complications including atelectasis and pneumonia and muscle weakness (Brull et al). The investigators posit that these complications are likely amplified in patients who require post-operative intensive care unit admission. In particular, the investigators hypothesize that cardiac surgery patients are at risk. Elective cardiac surgery patients are routinely admitted to the CVICU still intubated and ventilator-dependent immediately following surgery. The goal of uncomplicated cardiac surgery patients (fast track cardiac surgery patients) is to extubate them within 6 hours of ICU arrival. However, standard of care throughout the US does not include reversal of their neuromuscular blockade. By the time these patients meet extubation criteria, most providers believe that the neuromuscular blockade should have worn off and therefore do not administer reversal (Murphy et al). The investigators hypothesize that residual neuromuscular blockade delays time to extubation and increases respiratory complications in fast track cardiac surgery patients. By administering reversal of neuromuscular blockade in patients with a Train Of Four ratio of <0.9 we anticipate that there will be an increase from 60 to 85% of patients being successfully extubated within 6 hours of arrival to the ICU and a decrease in composite respiratory complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residual Neuromuscular Blockade
Keywords
Residual neuromuscular blockade, Reversal, Cardiac surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
Patient's will receive sugammadex at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight and TOF ratio by the pharmacy. It will be a one time dose at the end of the case
Arm Title
Neostigmine/glycopyrrolate
Arm Type
Active Comparator
Arm Description
Patient's will receive neostigmine/glycopyrrolate at the end of the case for reversal of neuromuscular blockade. The dosing will be determined based on the patient's weight (50mcg/kg of neostigmine with an equivalent volume to volume ratio of glycopyrrolate). It will be a one time dose at the end of the case
Arm Title
No reversal administered
Arm Type
No Intervention
Arm Description
No reversal administered at the end of the case
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
No additional information
Intervention Type
Drug
Intervention Name(s)
neostigmine/glycopyrolate
Intervention Description
No additional information
Primary Outcome Measure Information:
Title
Time from arrival in CVICU until extubation
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Tidal volumes prior to extubation
Time Frame
Prior to extubation, the tidal volumes the patient is generating will be documented
Title
Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula
Description
Assess how many liters of oxygen the patient requires to maintain pulse oximetry >92%
Time Frame
through study completion, an average of 1 year
Title
Lowest documented pulse oximetry
Time Frame
through study completion, an average of 1 year
Title
Number of participants requiring re-intubation
Description
If the patient is extubated in the intensive care unit but then develops respiratory failure and requires mechanical ventilation again
Time Frame
through study completion, an average of 1 year
Title
Bronchoscopy
Description
Change in baseline oxygen requirements from prior to the surgery
Time Frame
through study completion, an average of 1 year
Title
Pneumonia
Description
Change in baseline oxygen requirements from prior to the surgery
Time Frame
through study completion, an average of 1 year
Title
Intensive care unit length of stay
Time Frame
through study completion, an average of 1 year
Title
Mortality
Time Frame
28 days following the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All outpatients >18 years of age scheduled for elective coronary artery bypass graft surgery (CABG), aortic valve replacement (AVR), or combination CABG/AVR Exclusion Criteria: Chronic kidney disease stage IV or V Liver disease, defined as AST, ALT or ALP > 1.5x upper limit of normal Inpatient status Allergy to rocuronium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jarzebowski, MD
Organizational Affiliation
Henry Ford Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23076899
Citation
Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.
Results Reference
background
PubMed Identifier
29229252
Citation
Richey M, Mann A, He J, Daon E, Wirtz K, Dalton A, Flynn BC. Implementation of an Early Extubation Protocol in Cardiac Surgical Patients Decreased Ventilator Time But Not Intensive Care Unit or Hospital Length of Stay. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):739-744. doi: 10.1053/j.jvca.2017.11.007. Epub 2017 Nov 8.
Results Reference
result

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Residual Neuromuscular Blockade in Cardiac Surgery Patients

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