The Effect of Metoprolol on Anaesthesia, the Need for Analgesics, and Pain in Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Anaesthesia
研究概览
简要总结
The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the incidence of pain and life satisfaction will be evaluated.
详细描述
The purpose of the study is to test the effects of intraoperative metoprolol on 1) anaesthetic and alagesic use 2) pain during the early postoperative period and 3) the incidence of pain and lide satisfaction up to 12 months after the surgery. Adverse effects will be recorded as safety measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective breast surgery due to breast cancer
- •Voluntary
- •BMI ≥ 18 and ≤ 35 kg/m2
- •No regular use of beta-blockers or during the last 72 hours
- •No contraindications to beta-blockers
排除标准
- •Pregnancy or breast feeding
- •AV-block, degree II or III
- •Untreated cardiac insufficiency
- •Sinus bradycardia, heart rate < 45 / min or symptoms
- •Sick sinus syndrome
- •Cardiogenic shock
- •Severe peripheral vascular disorder
- •Systolic blood pressure < 100 mmHg
- •Long PQ-time, > 0,24 seconds
- •Known hypersensitivity to beta-blockers or the ingredients of the drug
研究组 & 干预措施
Metoprolol
Metoprolol infusion
干预措施: Metoprolol (Drug)
Normal saline
Equal volume of saline.
干预措施: Normal saline (Drug)
结局指标
主要结局
Anaesthesia
时间窗: Intraoperative
Total consumption of remifentanil
Postoperative pain
时间窗: First 4 postoperative hours
Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement
Long-term pain
时间窗: 1 year
The incidence and the level of pain at 12 months
次要结局
- Safety and tolerability(Perioperative)
- Distribution to the central nervous system(Perioperative)
- Life satisfaction(1 year)
- Anxiety(1 year)
- Depression(1 year)
研究者
Lasse Harkanen
DR
Kuopio University Hospital