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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513406
|Contact: Angie Ballew, DC, MS||(913) email@example.com|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Ashley McCowen 913-588-7419 firstname.lastname@example.org|
|Principal Investigator:||Anthony Kovac, MD||University of Kansas Medical Center|