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临床试验/ACTRN12617001619336
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.

The University of Melbourne0 个研究点目标入组 4,884 人开始时间: 2017年12月11日最近更新:

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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