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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 7, 2023

Interventions

  • Drug: Sugammadex
    • Sugammadex is indicated for the reversal of neuromuscular blockade.
  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Sugammadex
    • Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.
  • Active Comparator: Neostigmine
    • Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anthony Kovac, MD, Principal Investigator, University of Kansas Medical Center

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