Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
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
1 other identifier
interventional
201
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 surgery
Started Apr 2017
Typical duration for phase_3 surgery
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2017
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2022
CompletedResults Posted
Study results publicly available
March 7, 2023
CompletedMay 18, 2025
February 1, 2023
4.9 years
April 12, 2017
February 8, 2023
May 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure Participants' Recovery Time Post-Surgery
Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
1 day
Study Arms (2)
Neuromuscular blockade reversed with neostigmine/gly
EXPERIMENTALNeuromuscular blockade reversed with sugammadex
ACTIVE COMPARATORInterventions
At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
At the conclusion of surgery neuromuscular blockade reversed with sugammadex
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memoral Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. German Echeverry, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
German Echeverry, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 17, 2017
Study Start
April 7, 2017
Primary Completion
March 3, 2022
Study Completion
March 3, 2022
Last Updated
May 18, 2025
Results First Posted
March 7, 2023
Record last verified: 2023-02