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

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03513406
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Drug: Sugammadex; Drug: Neostigmine; Drug: Glycopyrrolate	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
• Actual Study Start Date: Mar 15, 2018
• Anticipated Primary Completion Date: Jan 20, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Time to return to a 90% Train of Four (TOF) neuromuscular twitch [Within 24 hours after surgery]

Secondary Outcome Measures

1. Time to endotracheal extubation [Within 24 hours after surgery]

2. Time to discharge from the operating room [Within 24 hours after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center

Investigators

• Principal Investigator: Anthony Kovac, MD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03513406
• Other Study ID Numbers: STUDY00141829
• First Posted: May 1, 2018
• Last Update Posted: May 3, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Kansas Medical Center: muscle function
• Additional relevant MeSH terms: Burns; Glycopyrrolate; Neostigmine

Study Results

No Results Posted as of May 3, 2022