Opioid-Free versus Opioid-Based Anaesthesia for secondary free-flap reconstruction surgery of the breast: A phase III multicentric randomized controlled study - OFOBA

Institut Curie0 个研究点目标入组 158 人开始时间: 2022年4月25日最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•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
•F.1.3.1 Number of subjects for this age range 158

•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.
•11.Patients with suspected difficulties in assessing pain on a scale.
•12.Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.

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