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OpenTrials
Completed

NCT Number: NCT03513406

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

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.

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Sugammadex is indicated for the reversal of neuromuscular blockade.

Neostigmine

Drug

Neostigmine is indicated for the reversal of neuromuscular blockade.

Glycopyrrolate

Drug

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

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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 1, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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