Residual Neuromuscular Blockade in Cardiac Surgery Patients

February 1, 2022 updated by: Mary Jarzebowski, Henry Ford Health System
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sugammadex
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
Drug: Sugammadex
No additional information
Active Comparator: Neostigmine/glycopyrrolate
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
Drug: neostigmine/glycopyrolate
No additional information
No Intervention: No reversal administered
No reversal administered at the end of the case

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time from arrival in CVICU until extubation
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tidal volumes prior to extubation
Time Frame: Prior to extubation, the tidal volumes the patient is generating will be documented
Prior to extubation, the tidal volumes the patient is generating will be documented
Need for unplanned noninvasive positive pressure ventilation or high flow nasal cannula
Time Frame: through study completion, an average of 1 year
Assess how many liters of oxygen the patient requires to maintain pulse oximetry >92%
through study completion, an average of 1 year
Lowest documented pulse oximetry
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Number of participants requiring re-intubation
Time Frame: through study completion, an average of 1 year
If the patient is extubated in the intensive care unit but then develops respiratory failure and requires mechanical ventilation again
through study completion, an average of 1 year
Bronchoscopy
Time Frame: through study completion, an average of 1 year
Change in baseline oxygen requirements from prior to the surgery
through study completion, an average of 1 year
Pneumonia
Time Frame: through study completion, an average of 1 year
Change in baseline oxygen requirements from prior to the surgery
through study completion, an average of 1 year
Intensive care unit length of stay
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Mortality
Time Frame: 28 days following the surgery
28 days following the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henry Ford Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary Jarzebowski, MD, Henry Ford Health Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Henryford

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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