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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116997
• Other study ID #: 17-207
• Status: Completed
• Phase: Phase 3
• Start date: April 7, 2017
• Est. completion date: March 3, 2022

Study information

• Verified date: February 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: March 3, 2022
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Neostigmine+glycopyrrolate
At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
• Sugammadex
At the conclusion of surgery neuromuscular blockade reversed with sugammadex

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memoral Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center