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

NCT03513406 | Completed Phase 3 FDA Drug

• 1 other identifier: STUDY00141829
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

muscle function

Outcome Measures

Primary Outcomes (1)

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

  Within 24 hours after surgery

Secondary Outcomes (2)

• Time to endotracheal extubation

  Within 24 hours after surgery

• Time to discharge from the operating room

  Within 24 hours after surgery

Study Arms (2)

Sugammadex

ACTIVE COMPARATOR

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

Drug: Sugammadex

Neostigmine

ACTIVE COMPARATOR

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

Drug: Neostigmine; Drug: Glycopyrrolate

Interventions

Sugammadex DRUG

Sugammadex is indicated for the reversal of neuromuscular blockade.

Sugammadex

Neostigmine DRUG

Neostigmine is indicated for the reversal of neuromuscular blockade.

Neostigmine

Glycopyrrolate DRUG

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

Neostigmine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing burn surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Sugammadex; Neostigmine; Glycopyrrolate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anthony Kovac, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: March 15, 2018
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (1)