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Trial record 27 of 187 for:    GLYCOPYRROLATE
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Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116997
Recruitment Status : Active, not recruiting
First Posted : April 17, 2017
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.

Condition or disease Intervention/treatment Phase
Surgery Drug: Neostigmine+glycopyrrolate Drug: Sugammadex Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Assessor Blinded Clinical Trial of Sugammadex Versus Neostigmine /Glycopyrrolate for Reversal of Rocuronium Induced Neuromuscular Blockade: Time to Discharge From Post Anesthesia Care Unit and Patient Satisfaction With Recovery
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Neuromuscular blockade reversed with neostigmine/gly Drug: Neostigmine+glycopyrrolate
At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
Active Comparator: Neuromuscular blockade reversed with sugammadex Drug: Sugammadex
At the conclusion of surgery neuromuscular blockade reversed with sugammadex


Outcome Measures
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Primary Outcome Measures :
  1. Measure Participants' Recovery Time Post-Surgery [ Time Frame: 1 day ]
    Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients age 18 years of age or greater who are capable of giving consent
  • Undergoing surgical procedures of expected length 6 </= hours requiring NMB

Exclusion Criteria:

  • Pregnancy
  • History of documented anaphylaxis or contraindication to any of the study medications
  • Active coronary disease with a positive cardiac stress test
  • History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 < 50% of predicted
  • Serum Creatinine >/= 2.0 mg/dL

  • Severe hepatic dysfunction accompanied by coagulopathy

    • Definition:
    • Known liver Disease AND
    • INR > 1.5 (except for patients on anticoagulants) AND
    • Platelet count <100,00/ul without other obvious cause
  • Chronic sustained release opioid for > 2 weeks duration pre op (in the 30 days prior to surgery)
  • Use of toremifene
  • Significant cognitive impairment or documented psychologic impairment
  • Myasthenia gravis or other neuromuscular disease
  • Patients who are not eligible for standard anesthetic induction, eg, those needing rapid sequence induction or awake fiberoptic bronchial intubation.
  • American Society of Anesthesiologists (ASA) Status > 3
Contacts and Locations
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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): NCT03116997


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: German Echeverry, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03116997    
Other Study ID Numbers: 17-207
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
neuromuscular blockade
sugammadex
SUG
 neostigmine
NEO/GLYCO
17-207
Additional relevant MeSH terms:
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Glycopyrrolate
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