Residual Neuromuscular Blockade in Cardiac Surgery Patients

Residual Neuromuscular Blockade Clinical Trial

Official title:

Residual Neuromuscular Blockade in Cardiac Surgery Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03574337
• Other study ID #: Henryford
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: February 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Residual Neuromuscular Blockade

Intervention

Drug:
• Sugammadex
No additional information
• neostigmine/glycopyrolate
No additional information

Locations

Country	Name	City	State
United States	Henry Ford Health Systems	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from arrival in CVICU until extubation		through study completion, an average of 1 year
Secondary	Tidal volumes prior to extubation		Prior to extubation, the tidal volumes the patient is generating will be documented
Secondary	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
Secondary	Lowest documented pulse oximetry		through study completion, an average of 1 year
Secondary	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
Secondary	Bronchoscopy	Change in baseline oxygen requirements from prior to the surgery	through study completion, an average of 1 year
Secondary	Pneumonia	Change in baseline oxygen requirements from prior to the surgery	through study completion, an average of 1 year
Secondary	Intensive care unit length of stay		through study completion, an average of 1 year
Secondary	Mortality		28 days following the surgery