Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irriga… (NCT05439213) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery
France181 participantsStarted 2022-06-16
Plain-language summary
The addition of adrenaline to the arthroscopic irrigation serum is used during rotator cuff surgery to limit intraoperative bleeding and ensure a clear view. Two concentrations of adrenaline are commonly used in practice: 1mg/L or 0.33 mg/L.
The aim of this study is to determine which of these two doses provides better clarity of the surgical field with less impact on the patient's cardiovascular parameters.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient over 18 years of age, having read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes)
* Patient with a rotator cuff pathology (subacromial impingement, long biceps tendinopathy or rotator cuff tendinopathy)
* Patient for whom an arthroscopic surgical indication has been given
Exclusion Criteria:
* Allergy to epinephrine
* History of Takotsubo cardiomyopathy
* Coagulation disorder
* Patient under court protection, guardianship or curatorship
* Patient not affiliated to the French social security system
* Patient participating in another therapeutic protocol
* Breastfeeding woman,
* Pregnant woman or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (\> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be post-menopausal unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal condition is defined as the absence of menstruation for 12 months without any other medical cause
* Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient