Opioid-free Anaesthesia Effectiveness in Thoracic Surgery - Objective Measurement With a Skin Conductance Algesimeter: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Intraoperative pain related stress [oscillations per second]
研究概览
简要总结
Proper assessment of pain and adequate analgesia in thoracic surgery is a challenging issue for medical practitioners. Basic aspects of thoracic anaesthesia are general anesthesia, intubation with double lumen tube and separation of lung ventilation, however proper analgesia needs to be standardized. Role of opioids in this clinical setting is reduced due to high risk of respiratory system complications. Instead, use of opioid free anaesthesia and regional anaesthesia is proposed. The aim of this study is to compare the use of opioid anaesthesia with opioid free anaesthesia and paravertebral block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index between 19-30 kg/m2,
- •American Society of Anesthesiology (ASA) physical status between 1 and 3
排除标准
- •lack of consent
- •significant coagulopathy,
- •contraindication to drugs used in protocol
- •history of chronic pain,
- •chest wall neoplastic invasion,
- •previous thoracic spine surgery,
- •mental state preventing from effective use of PCA device,
- •renal failure (GFR <60 ml/min/1,73 m2)
研究组 & 干预措施
Control group
General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1. The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally. Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane. The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA). This dose was titrated to achieve adequate analgesia. Each patient then commenced PCA. The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.
干预措施: Opioid Anesthesia (Drug)
Opioid Free Aneasthesia group
General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1. The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally. Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane. The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA). This dose was titrated to achieve adequate analgesia. Each patient then commenced PCA. The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.
干预措施: Opioid Free Anaesthesia (Drug)
结局指标
主要结局
Intraoperative pain related stress [oscillations per second]
时间窗: Period before induction of anaesthesia to termination of anaesthesia
During general anesthesia the pain-related stress was assessed using a method of skin conductance fluctuations. The measurement was based on changes in skin conductance that arise under the influence of a pain stimulus.
Intraoperative opioid usage [mg]
时间窗: Intraoperative period
Intraoperative usage of opioids was noted.
Intraoperative arterial blood pressure [mmHg]
时间窗: Intraoperative period
Non-invasive arterial blood pressure was recorded every 5 minutes during operation.
Intraoperative heart rate [bpm]
时间窗: Intraoperative period
Heart rate was recorded every 5 minutes during operation.
次要结局
- Postoperative analgesic requirement [mg](48 hours)
- Postoperative pain intensity (PHHPS)(48 hours)
- Postoperative arterial blood pressure [mmHg](48 hours)
- Overall postoperative analgesia satisfaction(48 hours)
- Postoperative heart rate [bmp](48 hours)
- Postoperative pain intensity (VAS)(48 hours)
- Postoperative sedation level(48 hours)
研究者
Piotr Palaczyński
Principal Investigator
Medical University of Silesia