Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
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|ClinicalTrials.gov Identifier: NCT03513406|
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Burns||Drug: Sugammadex Drug: Neostigmine Drug: Glycopyrrolate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Active Comparator: Sugammadex
Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV.
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.
Neostigmine is indicated for the reversal of neuromuscular blockade.
Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.
- Time to return to a 90% Train of Four (TOF) neuromuscular twitch [ Time Frame: Within 24 hours after surgery ]
- Time to endotracheal extubation [ Time Frame: Within 24 hours after surgery ]
- Time to discharge from the operating room [ Time Frame: Within 24 hours after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513406
|Contact: Angie Ballew, DC, MS||(913) firstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Ashley McCowen 913-588-7419 email@example.com|
|Principal Investigator:||Anthony Kovac, MD||University of Kansas Medical Center|