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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2021-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Monitoring of Hypnosis State During General Anesthesia With Propofol by Patient State Index From SEDLine®

NCT02706665

Hypnotic Effect

COMPLETED

A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation

NCT05015361

Local Anesthesia Assisted Sedation

COMPLETED PHASE2

The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes

NCT07022951

Anesthesia Sedation Monitored Anesthesia Care +6 more

RECRUITING

Binaural Sound Effects for General Anesthesia

NCT05431881

Anesthesia, General

UNKNOWN NA

The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients

NCT06353516

Postoperative Cognitive Dysfunction

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SedLine Vs Comparator Test Group

Group Type EXPERIMENTAL

SedLine Vs Comparator Test Group

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SedLine Vs Comparator Test Group

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No