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Trial record 27 of 187 for:    GLYCOPYRROLATE

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

Tracking Information
First Submitted Date  ICMJE April 12, 2017
First Posted Date  ICMJE April 17, 2017
Last Update Posted Date April 3, 2020
Actual Study Start Date  ICMJE April 7, 2017
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Surgery
Intervention  ICMJE
  • Drug: Neostigmine+glycopyrrolate
    At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
  • Drug: Sugammadex
    At the conclusion of surgery neuromuscular blockade reversed with sugammadex
Study Arms  ICMJE
  • Experimental: Neuromuscular blockade reversed with neostigmine/gly
    Intervention: Drug: Neostigmine+glycopyrrolate
  • Active Comparator: Neuromuscular blockade reversed with sugammadex
    Intervention: Drug: Sugammadex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 2, 2020)
201
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2017)
202
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03116997
Other Study ID Numbers  ICMJE 17-207
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: German Echeverry, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP