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OpenTrials
Completed

NCT Number: NCT03865316

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SedLine Vs Comparator Test Group

Device

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

Primary outcomes

  1. Correlation of Sedation Indices Performance Across Anesthesia Range

    Time frame: Duration of surgery

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

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2019
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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