EUCTR2022-001139-98-FR
Active, not recruiting
Phase 1
Opioid-Free versus Opioid-Based Anaesthesia for secondary free-flap reconstruction surgery of the breast: A phase III multicentric randomized controlled study - OFOBA
ConditionsAnaesthesia during secondary free flap reconstruction surgery of the breast.MedDRA version: 21.1Level: LLTClassification code 10002323Term: Anesthesia generalSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10006305Term: Breast reconstructionSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Anaesthesia during secondary free flap reconstruction surgery of the breast.
- Sponsor
- Institut Curie
- Enrollment
- 158
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Women aged 18 or older.
- •2\.Patients with a French health insurance coverage (having a French social security number).
- •3\.Patient eligible for secondary free flap reconstruction surgery of the breastunder general anaesthesia.
- •4\.Patient who has given written consent to participate in accordance with the regulations.
- •5\.Having a negative blood pregnancy test for patients of childbearing age.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 158
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
- •2\.Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
- •3\.Pulse below 50bpm during anaesthesia consultation and/or under beta\-blocker treatment.
- •4\.Treatment with ACEI/ARB.
- •5\.Severe asthma.
- •6\.Symptomatic gastric or duodenal ulcer with or without treatment.
- •7\.Baseline systolic blood pressure \< 100 mmHg.
- •8\.Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
- •9\.Patient already included in another therapeutic trial evaluating an experimental molecule.
- •10\.Persons deprived of liberty or under guardianship.
Outcomes
Primary Outcomes
Not specified
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