Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant

• ClinicalTrials.gov Identifier: NCT03116997
• Recruitment Status: Active, not recruiting
• First Posted: April 17, 2017
• Last Update Posted: April 3, 2020
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: April 12, 2017
• First Posted Date: April 17, 2017
• Last Update Posted Date: April 3, 2020
• Actual Study Start Date: April 7, 2017
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Surgery

Intervention

• 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

• Experimental: Neuromuscular blockade reversed with neostigmine/gly
  Intervention: Drug: Neostigmine+glycopyrrolate
• Active Comparator: Neuromuscular blockade reversed with sugammadex
  Intervention: Drug: Sugammadex

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 2, 2020): 201
• Original Estimated Enrollment (submitted: April 12, 2017): 202
• Estimated Study Completion Date: April 2021
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03116997
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Memorial Sloan Kettering Cancer Center
• Study Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: German Echeverry, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: April 2020