Last updated: April 4, 2024
Sponsor: Institut Curie
Overall Status: Active - Recruiting
Phase
3
Condition
Breast Cancer
Cancer
Treatment
Dexmedetomidine
Clinical Study ID
NCT05439005
IC 2021-07
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women aged 18 or older.
- Patients with a French health insurance coverage (having a French social securitynumber).
- Patient eligible for free flap reconstruction surgery of the breastunder generalanaesthesia.
- Patient who has given written consent to participate in accordance with theregulations.
- Having a negative blood pregnancy test for patients of childbea ring age.
Exclusion
Exclusion Criteria:
- Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine,propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine,ropivacaine, droperidol, ondansetron).
- Known history of heart failure, arrhythmias and/or ischemic heart disease and/orsevere renal insufficiency.
- Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
- Treatment with ACEI/ARB.
- Severe asthma.
- Symptomatic gastric or duodenal ulcer with or without treatment.
- Baseline systolic blood pressure < 100 mmHg.
- Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesicspreoperatively.
- Patient already included in another therapeutic trial evaluating an experimentalmolecule.
- Persons deprived of liberty or under guardianship.
- Patients with suspected difficulties in assessing pain on a scale.
- Inability to undergo trial medical monitoring due to geographic, social orpsychological reasons.
Study Design
Total Participants: 158
Treatment Group(s): 1
Primary Treatment: Dexmedetomidine
Phase: 3
Study Start date:
December 07, 2022
Estimated Completion Date:
March 15, 2026
Connect with a study center
Institut Curie Paris
Paris, 75005
FranceActive - Recruiting
Institut Curie Saint-Cloud
Saint-Cloud, 92210
FranceActive - Recruiting
Gustave Roussy, Cancer Campus, Grand Paris
Villejuif,
FranceActive - Recruiting
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