TerminatedNot Applicable

The Comparability of Bispectral Index and Neurosense During Anesthesia

Stopped: Differences between BIS and Neurosense are important. This study can be terminated.

France40 participantsStarted 2009-05

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia

Timeframe: at the end of each case

Trial details

NCT IDNCT00910416

SponsorHopital Foch

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-12

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