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

University of Kansas

Status and phase: Completed; Phase 3

Conditions: Burns

Treatments: Drug: Neostigmine; Drug: Glycopyrrolate; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT03513406

STUDY00141829

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Sugammadex

Active Comparator group

Description:

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

Treatment:

Drug: Sugammadex

Neostigmine

Active Comparator group

Description:

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

Treatment:

Drug: Neostigmine

Drug: Glycopyrrolate