University of Kansas Medical Center

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

Purpose

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.

Condition

Burns

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Sugammadex	Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.	Drug: Sugammadex Sugammadex is indicated for the reversal of neuromuscular blockade.
Active Comparator Neostigmine	Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV.	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.

More Details

Status: Completed
Sponsor: University of Kansas Medical Center

Study Contact

Notice

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