Phase 4
N=90
Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04570150 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Time to PACU Discharge — 123; 125 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Neostigmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to PACU Discharge |
123; 125 | — |
| SECONDARY Compare Proportional Changes Between Baseline Peak Expiratory Flow Rates and Postoperative Peak Expiratory Flow Rates Between Subjects Receiving Sugammadex and Those Receiving Neostigmine. |
0.57; 0.65 | — |
| SECONDARY Compare Proportional Changes Between Baseline Peak Forced Expiratory Volume Over 1 Second (FEV1) and Postoperative FEV1 Between Subjects Receiving Sugammadex and Those Receiving Neostigmine. |
0.63; 0.73 | — |
| SECONDARY Compare Proportional Changes Between Baseline Forced Vital Capacity (FVC) and Postoperative FVC Between Subjects Receiving Sugammadex and Those Receiving Neostigmine. |
0.62; 0.72 | — |
| SECONDARY Compare Proportional Changes Between Baseline PaO2 Measured Via Arterial Blood Gas and Postoperative PaO2 (Measured Via Arterial Blood Gas) Between Subjects Receiving Sugammadex and Those Receiving Neostigmine. |
0.74; 0.9 | — |
| SECONDARY Compare Proportional Changes Between Baseline PaCO2 Measured Via Arterial Blood Gas and Postoperative PaCO2 (Measured Via Arterial Blood Gas) Between Subjects Receiving Sugammadex and Those Receiving Neostigmine. |
1.08; 1.07 | — |
Summary
This study assesses the efficacy of sugammadex against neostigmine for hastening recovery from neuromuscular blockade and optimizing pulmonary function in obese patients with obstructive sleep apnea presenting for outpatient surgery. Both drugs are used in anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and maintaining general anesthesia.
Eligibility Criteria
Inclusion Criteria
- obese (body mass index [BMI] >30 kg/m2)
- diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway pressure [CPAP] use)
- scheduled for surgery requiring general anesthesia and neuromuscular blockade
Exclusion Criteria
- history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction
- history of difficult tracheal intubation
- history of adverse reaction to anesthesia
- history of adverse reaction to rocuronium, sugammadex, and/or neostigmine/glycopyrrolate
Data sourced from ClinicalTrials.gov (NCT04570150). 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.