The Comparability of Bispectral Index and Neurosense During Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.

Related Clinical Trials

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

EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol

NCT02893904

Anesthesia

COMPLETED NA

Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

NCT00391963

Anesthesia, General

COMPLETED

Reliability of BIS Monitoring in Neurosurgical Patients

NCT01483547

Sovra and Intra Tentorial Lesions

COMPLETED

The Influence of Age on Bispectral Index Associated With Propofol-induced Sedation

NCT02046720

Anesthesia

COMPLETED PHASE3

EEG-based Depth of Anesthesia-monitoring, Effects on Dosage and Cognition

NCT04529304

Postoperative Complications Delayed Emergence From Anesthesia 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.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

patients receiving iv anesthesia

propofol, remifentanil, atracurium

Intervention Type DRUG

propofol, remifentanil, atracurium dosages are adapted according to clinician's judgment

EEG monitoring

Intervention Type DEVICE

simultaneous monitoring with Bis and Neurosense

patients receiving balanced anesthesia

propofol, remifentanil, atracurium, sevoflurane

Intervention Type DRUG

dosages are adapted according to clinician's judgment

EEG monitoring

Intervention Type DEVICE

simultaneous monitoring with Bis and Neurosense

Interventions

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

propofol, remifentanil, atracurium

propofol, remifentanil, atracurium dosages are adapted according to clinician's judgment

Intervention Type DRUG

propofol, remifentanil, atracurium, sevoflurane

dosages are adapted according to clinician's judgment

Intervention Type DRUG

EEG monitoring

simultaneous monitoring with Bis and Neurosense

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 requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)

Exclusion Criteria

* Pregnant women,
* Allergy to propofol, remifentanil, morphine, muscle relaxant, or to a component,
* Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
* History of neurological disorder or central brain lesion, of muscle disease,
* Patient carrying a pacemaker,
* Patients receiving a psychotropic treatment or a morphine agonist-antagonist,
* Alcoholic patients and patients taking opiates,
* Surgery with extracorporeal circulation,
* Surgical position incompatible with an adequate positioning of the probe.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No