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NCT03513406 Clinical Trial

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

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03513406
Other study ID # STUDY00141829
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 15, 2018
Est. completion date March 7, 2023

Study information
Verified date September 2023
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date March 7, 2023
Est. primary completion date March 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sugammadex
Sugammadex is indicated for the reversal of neuromuscular blockade.
• Neostigmine
Neostigmine is indicated for the reversal of neuromuscular blockade.
• Glycopyrrolate
Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to return to a 90% Train of Four (TOF) neuromuscular twitch Within 24 hours after surgery
Secondary Time to endotracheal extubation Within 24 hours after surgery
Secondary Time to discharge from the operating room Within 24 hours after surgery
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