ACTRN12617001619336招募中3 期
The effect of perioperative ketamine on the risk of development of chronic post-surgical pain in patients undergoing elective or expedited surgery and anaesthesia for major orthopaedic, abdominal or non cardiac thoracic surgery.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,884
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years(—)
- 性别
- All
入选标准
- •Patients with ASA 1-3 undergoing elective or expedited surgery and anaesthesia for abdominal surgery involving an expected skin incision at least 8cm in length and including open herniorraphy; non-cardiac thoracic surgery, including mastectomy and breast reconstruction surgery, and including all video-assisted thoracoscopic surgery; hip, knee and shoulder joint arthroplasty and spinal surgery involving an expected skin incision at least 8cm; plan for postoperative opioid analgesia; planned hospital stay of at least one night post-operatively; expected to be alive at 12 months post index surgery.
排除标准
- •Patients unable to provide written informed consent
- •Patients who are pregnant or lactating
- •Body mass index (BMI) over 40 kg/m2 and weight over 130kg
- •ASA physical status 4 or 5
- •Planned use of intra or postoperative continuous intravenous lignocaine infusion
- •Uncontrolled hypertension (SBP >180mmHg) on admission
- •Poorly controlled atrial fibrillation (ventricular response rate >120/min) on admission
- •Uncontrolled heart failure
- •Intracranial surgery or raised intracranial pressure
- •History of haemorrhagic stroke
- •Severe impairment of liver function
- •Previous adverse reaction to ketamine
- •Documented complex regional pain syndrome
- •History of epilepsy or convulsions
- •History of psychosis, or of illicit drug use or known illegal activities
- •Previously randomised to the ROCKet trial
研究者
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