Phase 3
N=201
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03116997 ↗Enrolled (actual)
201
Serious AEs
2.0%
Results posted
Mar 2023
Primary outcome: Primary: Measure Participants' Recovery Time Post-Surgery — 3.59; 3.62 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Neostigmine+glycopyrrolate (Drug); Sugammadex (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure Participants' Recovery Time Post-Surgery |
3.59; 3.62 | — |
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.
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 /= 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 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
Data sourced from ClinicalTrials.gov (NCT03116997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.