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

Primary Purpose

Burns

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Sugammadex

Neostigmine

Glycopyrrolate

About this trial

This is an interventional treatment trial for Burns focused on measuring muscle function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Sugammadex

Neostigmine

Arm Description

Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.

Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.

Outcomes

Primary Outcome Measures

Time to return to a 90% Train of Four (TOF) neuromuscular twitch

Secondary Outcome Measures

Time to endotracheal extubation

Time to discharge from the operating room

Full Information

NCT ID

NCT03513406

First Posted

April 19, 2018

Last Updated

September 25, 2023

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03513406

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

March 15, 2018 (Actual)

Primary Completion Date

March 7, 2023 (Actual)

Study Completion Date

March 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

Keywords

muscle function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sugammadex

Arm Type

Active Comparator

Arm Description

Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.

Arm Title

Neostigmine

Arm Type

Active Comparator

Arm Description

Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.

Intervention Type

Drug

Intervention Name(s)

Sugammadex

Intervention Description

Sugammadex is indicated for the reversal of neuromuscular blockade.

Intervention Type

Drug

Intervention Name(s)

Neostigmine

Intervention Description

Neostigmine is indicated for the reversal of neuromuscular blockade.

Intervention Type

Drug

Intervention Name(s)

Glycopyrrolate

Intervention Description

Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.

Primary Outcome Measure Information:

Title

Time to return to a 90% Train of Four (TOF) neuromuscular twitch

Time Frame

Within 24 hours after surgery

Secondary Outcome Measure Information:

Title

Time to endotracheal extubation

Time Frame

Within 24 hours after surgery

Title

Time to discharge from the operating room

Time Frame

Within 24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Kovac, MD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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