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CompletedNCT03513406Updated Sep 28, 2023

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

A Phase 3 interventional study of Sugammadex and Neostigmine in Burns, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by University of Kansas Medical Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2023, 3 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Burns

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Keywords

  • muscle function
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Undergoing burn surgery under general anesthesia

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Active comparator
    Sugammadex

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

    Drug: Sugammadex

  • Active comparator
    Neostigmine

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

    Drug: Neostigmine · Drug: Glycopyrrolate

Interventions

  • DrugSugammadex

    Sugammadex is indicated for the reversal of neuromuscular blockade.

  • DrugNeostigmine

    Neostigmine is indicated for the reversal of neuromuscular blockade.

  • DrugGlycopyrrolate

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

06

What researchers measure

Primary outcomes

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

    Time frame: Within 24 hours after surgery

Secondary outcomes

  1. Time to endotracheal extubation

    Time frame: Within 24 hours after surgery

  2. Time to discharge from the operating room

    Time frame: Within 24 hours after surgery

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03513406
Lead sponsor
University of Kansas Medical Center
Responsible party
Sponsor
First posted
May 1, 2018
Start date
Mar 15, 2018
Primary completion
Mar 7, 2023
Completion
Mar 7, 2023
Last update
Sep 28, 2023

Study contacts

Anthony Kovac, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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