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Trial record 54 of 186 for:    GLYCOPYRROLATE

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
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 15, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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.




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

Secondary Outcome Measures :
  1. Time to endotracheal extubation [ Time Frame: Within 24 hours after surgery ]
  2. Time to discharge from the operating room [ Time Frame: Within 24 hours after surgery ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Angie Ballew, DC, MS (913) 945-7420 aballew@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Ashley McCowen    913-588-7419    amccowen@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Anthony Kovac, MD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03513406     History of Changes
Other Study ID Numbers: STUDY00141829
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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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:
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Glycopyrrolate
Burns
Wounds and Injuries
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists