Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia

Masimo

Status: Completed

Conditions: Anesthesia

Treatments: Device: SedLine Vs Comparator Test Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT03865316

APPL0009

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

SedLine Vs Comparator Test Group

Experimental group

Treatment:

Device: SedLine Vs Comparator Test Group