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

February 8, 2023 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memoral Sloan Kettering Basking Ridge
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memoral Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2017

Primary Completion (Actual)

March 3, 2022

Study Completion (Actual)

March 3, 2022

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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