Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Heart surgery without morphine: safer or not?

NCT ID NCT04940689

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether avoiding morphine during heart surgery could reduce common complications like breathing problems, confusion, and gut issues. 268 adults having planned heart surgery were randomly assigned to receive either standard morphine-based anesthesia or a combination of dexmedetomidine and lidocaine. The researchers tracked major complications in the first 48 hours after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexmedetomidine and lidocaine (instead of morphine)
What this could lead to
If it works, this could lead to safer anesthesia for heart surgery patients, with fewer side effects like breathing trouble or confusion.
What could go wrong
This is a single completed study with 268 people. Results may not apply to all heart surgeries, and the new drugs have their own risks like low blood pressure or slow heart rate.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

268 people

The number who actually took part.

Started

Jul 2021

Finished

Aug 2024

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

18 to 75 years

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 having planned cardiac surgery under cardiopulmonary bypass, with at least one coronary artery bypass grafting and rf at least one internal mammary artery as graft; possible association with aortic valve replacement * Patient having red and understood the information letter and signed the consent form * For women : of childbearing age, need to confirm the absence of an active pregnancy by a negative blood pregnancy test within 48 hours prior to inclusion / menopausal (amenorrhea not medically induced for at least 12 months before the inclusion visit) * Patient affiliated to a social security scheme Exclusion Criteria: * Preoperative treatment with morphine or its derivatives (including tramadol) in the 15 days preceding the inclusion visit * Pre-existing high-degree conduction disorder * Bradycardia \< 50 bpm * Oxygen therapy prior to inclusion * Heart failure with LVEF \<40% * BMI ≥ 35 kg/m² * Myocardial suffering in the 5 days preceding inclusion * Patient in shock * Known adrenal insufficiency and / or long-term systemic corticosteroid treatment (equivalent to hydrocortisone hemisuccinate ≥ 20 mg / day) * Combined surgery other than aortic valve * Long-term non-invasive ventilation (including for obstructive sleep apnea syndrome) * Any antecedent or active practice (s) of drug addiction; * Contraindication to one of the experimental and / or non-experimental treatments: dexmedetomidine, lidocaine, dexamethasone, ketamine, remifentanil or morphine * Acute cerebrovascular pathology, * Severe hepatic insufficiency (factor V level \<50%), * Pre-existing cognitive disorders, * Patient for whom the CAM-ICU questionnaire cannot be carried out (deaf patients for example), * Pregnant or parturient or breastfeeding woman * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship * Patient participating in another drug trial or having participated in another drug trial within 1 month before randomization

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Anesthesia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Amiens Univesrity Hospital

    Amiens, France

  • CAEN university Hospital

    Caen, France

  • Lille Hopistal University

    Lille, France

  • Montpellier University Hospital

    Montpellier, France

  • Rouen University Hospital

    Rouen, France, Normandy, 76031, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.