Phase 4
N=6,824
Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications
Respiratory Complication · Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT04263363 ↗Enrolled (actual)
6,824
Serious AEs
0.1%
Results posted
Jul 2025
Primary outcome: Primary: Time to "Fitness for Discharge" From the Recovery Room — 165.64; 154.60 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex 100 MG/ML [Bridion] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to "Fitness for Discharge" From the Recovery Room |
165.64; 154.60 | — |
| PRIMARY Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%) |
18; 9; 12,221 | — |
| SECONDARY Percentage of Patients Who Had Intraoperative Lung Protective Ventilation |
— | — |
| SECONDARY Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%) |
421; 1170; 10,657 | — |
| SECONDARY Duration of Supplemental Oxygen Needed by High-risk Patients |
— | — |
| SECONDARY Postoperative Reintubation Rate |
13; 4 | — |
| SECONDARY Number of Patients With Unplanned Upgrade of Care |
128; 16; 12,104 | — |
| SECONDARY Percentage of Patients Who Had Train of Four Ratio Measurement |
2704 | — |
Summary
The purpose of this study is to:
1. Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice.
2. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.
Eligibility Criteria
Inclusion Criteria
- UCLA Ronald Reagan or Santa Monica patients aged 18 and older who had a general anesthetic with either rocuronium or vecuronium.
- Patients who receive sugammadex from the specified study supply
Exclusion Criteria
- Patients under the age of 18
- Patients with a preoperative glomerular filtration rate less than 30 or on hemodialysis
- Patients with known hypersensitivity to any of the following: rocuronium, vecuronium, sugammadex, neostigmine or glycopyrrolate
- Patients with known neuromuscular disease
- Patients who remain intubated after surgery or leave the operating room with a tracheostomy in-situ
- Patients who did not receive reversal of neuromuscular blockade (with neostigmine in the pre-period or sugammadex in the post-period).
Data sourced from ClinicalTrials.gov (NCT04263363). 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.