Residual Neuromuscular Blockade in Cardiac Surgery Patients

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• Status: Withdrawn
• Conditions: Residual Neuromuscular Blockade
• Intervention / Treatment: Drug: Sugammadex; Drug: neostigmine/glycopyrolate

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: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Time from arrival in CVICU until extubation	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volumes prior to extubation		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	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		through study completion, an average of 1 year
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	through study completion, an average of 1 year
Bronchoscopy	Change in baseline oxygen requirements from prior to the surgery	through study completion, an average of 1 year
Pneumonia	Change in baseline oxygen requirements from prior to the surgery	through study completion, an average of 1 year
Intensive care unit length of stay		through study completion, an average of 1 year
Mortality		28 days following the surgery

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Mary Jarzebowski, MD, Henry Ford Health Systems

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac surgery; Reversal; Residual neuromuscular blockade
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID 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