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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Clarity of the arthroscopic surgical field
研究概览
简要总结
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.
详细描述
A prospective, randomised, double-blind, multicentre study in two parallel groups of 85 patients comparing two concentrations of adrenaline in the irrigation fluid of an arthroscopy (0.33 mg/L vs. 1 mg/L):
Maximum duration of patient participation in the study = 1 day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1
adrenaline 0,33 mg per litter
干预措施: Adrenaline 0,33 Mg/mL Solution for Injection (Drug)
Group 2
adrenaline 1 mg per litter
干预措施: Adrenaline 1 Mg/mL Solution for Injection (Drug)
结局指标
主要结局
Clarity of the arthroscopic surgical field
时间窗: Day 1
The primary endpoint is the clarity of the arthroscopic surgical field assessed by the investigator at the end of the surgical procedure on a numerical scale of 0 to 10, where zero means total opacity throughout the procedure and ten means total clarity throughout the procedure.)
次要结局
- Average blood pressure(Day 1)
- Average heart rate(Day 1)
- Significant changes in blood pressure(Day 1)
- Significant changes in heart rate(Day 1)
- Evolution of the pressures of the arthropump(Day 1)
- Duration of intervention(Day 1)
- Amount of saline used for the arthroscopic procedure (in litres)(Day 1)