Heart surgery without morphine: safer or not?
NCT ID NCT04940689
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 Hide 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.
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.
- Can heart stent patients go home in 6 hours?
- Newer sedative faces off against propofol in heart patients
- Can AI read heart scans to predict the next heart attack?
- Could a whiff of xenon replace the Pre-Surgery chill pill?
- Can a new drug cool the hidden inflammation that fuels heart disease?
- New CT scanner aims to cut unnecessary heart procedures