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New study aims to cut surgery risks by tracking anesthesia levels

NCT ID NCT05893030

Disease control Sponsor: Centre Hospitalier Universitaire de Saint Etienne Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether closely monitoring the amount of sedation and pain medication given during surgery can prevent serious complications like kidney injury, heart problems, and death. It involves 1,132 high-risk patients over 75 or with conditions like heart disease. The goal is to see if this approach reduces organ damage and improves survival after major surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * patients affiliated to the French Social Security; * informed and signed consent to participating in the study; * planned postoperative hospitalization \> 48 hours; * patients over 75 years of age with at least one of the following postoperative risk factors: * ischemic coronary disease; * history of compensated or prior heart failure; * stroke; * significant arrhythmias: fibrillation or auricular flutter with ventricular response \> 100/minute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the second or third degree); * peripheral vascular disease; * chronic obstructive pulmonary disease; * chronic respiratory failure; * renal insufficiency, defined by a creatinine \> 175 µmol.l-1 (2 mg.dl-1); * insulin therapy for diabetes; * active cancer; * chronic alcohol abuse; * dementia. * elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device Non inclusion criteria: * Patients who meet one or more of the preoperative following criteria will not be included: * acute heart failure or acute myocardial infarction; * complete arrhythmia due to atrial fibrillation; * acute respiratory failure or pneumonia; * septic shock; * acute stroke; * cardiac surgery; * open chest surgery; * opioid free anesthesia; * intraoperative ketamine at a dose \> 0.25 mg.kg-1; \> 0.25 mg/kg or or intravenous electric syringe * lidocaine or dexmedetomidine by continuous infusion; * refusal to participate in the study; * patient under guardianship, conservatorship, or unable to understand the study.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sedation and analgesia monitoring

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM - Centre Hôpital Marseille Nord

    NOT_YET_RECRUITING

    Marseille, 13015, France

  • Chru de Besancon

    NOT_YET_RECRUITING

    Besançon, 25030, France

  • Chu Clermont-Ferrand

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63000, France

  • Chu D'Amiens Picardie

    RECRUITING

    Amiens, 80054, France

  • Chu Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • Chu St-Etienne

    RECRUITING

    Saint-Etienne, 42100, France

  • Chu de Grenoble

    NOT_YET_RECRUITING

    Grenoble, 38700, France

  • Chu de Lille

    RECRUITING

    Lille, 59037, France

  • Chu de Nantes

    NOT_YET_RECRUITING

    Nantes, 44093, France

  • Chu de Nimes

    RECRUITING

    Nîmes, 30000, France

  • Chu de Poitiers

    RECRUITING

    Poitiers, 86000, France

  • Chu de Toulouse

    RECRUITING

    Toulouse, 31059, France

  • Clinique Victor Pauchet

    RECRUITING

    Amiens, 80090, France

  • Hopital Bichat Claude Bernard

    RECRUITING

    Paris, 75018, France

  • Hôpital Saint Charles

    NOT_YET_RECRUITING

    Saint-Dié, 88100, France

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94800, France

  • Médipole Lyon Villeurbanne

    RECRUITING

    Villeurbanne, 69100, France

  • Polyclinique Bordeaux Nord Aquitaine

    RECRUITING

    Bordeaux, 33300, France