Status:
COMPLETED
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
Lead Sponsor:
Masimo Corporation
Conditions:
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 compar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03865316
Start Date
January 25 2019
End Date
March 11 2021
Last Update
April 11 2022
Active Locations (1)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817