Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery

September 25, 2023 updated by: University of Kansas Medical Center
The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 3

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
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing burn surgery under general anesthesia

Exclusion Criteria:

  • Patients without a non-burned upper extremity
  • Renal insufficiency or failure
  • Sensitivity or hypersensitivity reaction to sugammadex
  • Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sugammadex
Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.
Drug: Sugammadex
Sugammadex is indicated for the reversal of neuromuscular blockade.
Active Comparator: Neostigmine
Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.
Drug: Neostigmine
Neostigmine is indicated for the reversal of neuromuscular blockade.
Drug: Glycopyrrolate
Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to return to a 90% Train of Four (TOF) neuromuscular twitch
Time Frame: Within 24 hours after surgery
Within 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to endotracheal extubation
Time Frame: Within 24 hours after surgery
Within 24 hours after surgery
Time to discharge from the operating room
Time Frame: Within 24 hours after surgery
Within 24 hours after surgery

Collaborators and Investigators

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

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Anthony Kovac, MD, University of Kansas Medical Center

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)

March 15, 2018

Primary Completion (Actual)

March 7, 2023

Study Completion (Actual)

March 7, 2023

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00141829

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.

No

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.

Subscribe