Residual Neuromuscular Blockade in Cardiac Surgery Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Residual Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Sugammadex

Intervention Type DRUG

No additional information

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

Group Type ACTIVE_COMPARATOR

neostigmine/glycopyrolate

Intervention Type DRUG

No additional information

No reversal administered

No reversal administered at the end of the case

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sugammadex

No additional information

Intervention Type DRUG

neostigmine/glycopyrolate

No additional information

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes