N/A
N=108
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03865316 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Correlation of Sedation Indices Performance Across Anesthesia Range — 0.8314 Pearson r
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SedLine Vs Comparator Test Group (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation of Sedation Indices Performance Across Anesthesia Range |
0.8314 | — |
Summary
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
Eligibility Criteria
Inclusion Criteria
- Patients 18 years old and older at the time of consent.
- ASA status I, II, or III.
- English-speaking subjects.
- Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).
Exclusion Criteria
- Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.
- Subjects who are developmentally delayed.
- Subjects deemed not suitable for study at the discretion of the investigator.
Data sourced from ClinicalTrials.gov (NCT03865316). 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.