NCT03574337

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

29 days

First QC Date

May 28, 2018

Last Update Submit

February 1, 2022

Conditions

Residual Neuromuscular Blockade

Keywords

Residual neuromuscular blockadeReversalCardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Time from arrival in CVICU until extubation

    through study completion, an average of 1 year

Secondary Outcomes (8)

  • 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

    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

    through study completion, an average of 1 year

  • Bronchoscopy

    through study completion, an average of 1 year

  • +3 more secondary outcomes

Study Arms (3)

Sugammadex

ACTIVE COMPARATOR

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

Neostigmine/glycopyrrolate

ACTIVE COMPARATOR

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 reversal administered

NO INTERVENTION

No reversal administered at the end of the case

Interventions

SugammadexDRUG

No additional information

Sugammadex
neostigmine/glycopyrolateDRUG

No additional information

Neostigmine/glycopyrrolate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

  • 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.

    PMID: 23076899BACKGROUND

  • 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.

    PMID: 29229252RESULT

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

SugammadexNeostigmine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Mary Jarzebowski, MD

    Henry Ford Health Systems

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

May 28, 2018

First Posted

July 2, 2018

Study Start

August 1, 2018

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)