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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Glycopyrrolate; Neostigmine

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 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