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

Masimo Corporation108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

108

Conditions

Anesthesia

Interventions

SedLine Vs Comparator Test GroupDEVICE

Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UC Davis Medical Center

Sacramento, California, United States

Outcomes

Primary Outcomes

Correlation of Sedation Indices Performance Across Anesthesia Range

The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.

Time frame: Duration of surgery

Data from ClinicalTrials.gov

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