Phase 4
N=120
Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT03679611 ↗Enrolled (actual)
120
Serious AEs
1.7%
Results posted
Mar 2025
Primary outcome: Primary: Time to Discharge From Operating Room — 13.0; 13.5 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex Sodium (Drug); Neostigmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Discharge From Operating Room |
13.0; 13.5 | — |
| SECONDARY Time the Patient Open Eyes to Command |
6.00; 7.00 | — |
Summary
Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (NMBD). This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years old
- Diagnosed Obstructive Sleep Apnea patients by polysomnography
- Scheduled elective bariatric surgery
Exclusion Criteria
- Age<18 years old
- Allergy to rocuronium
- Allergy to sugammadex
- Allergy to neostigmine
- Malignant hyperthermia
- Hepatic insufficiency
- Renal insufficiency
- Neuromuscular Disease
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03679611). 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.