Impact of Dexmedetomidine as an Opioid-Sparing Strategy in Thoracoscopic Surgery: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- The difference in the perioperative dosage of fentanyl between the two groups.
研究概览
简要总结
Numerous studies in recent years have shown that the use of opioid-free analgesia can reduce opioid use and length of stay in the recovery room, as published in the journals Anesthesia & Analgesia1. Compared with traditional opioid analgesic anesthesia, opioid-free analgesic anesthesia can be used to reduce postoperative respiratory complications, postoperative nausea and vomiting, and postoperative opioid needs. During surgery, opioid analgesics may have immunosuppressive effects, but different anesthesia/analgesia methods will change the individual's stress response, affect the human body's cellular immunity, and may even lead to changes in angiogenesis growth factors associated with cancer recurrence, so it is likely to affect the prognosis of cancer patients. In addition, Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, can replace opioids for pain relief during surgery, providing superior analgesia and reducing opioid use while reducing the need for general anesthetics amount, thus avoiding suppression of immune system function. A study in the Journal of Anaesthesiology Clinical Pharmacology pointed out that Dexmedetomidine can be used to replace opioid analgesics in surgical anesthesia, and there was no difference in the use of rescue opioid analgesics during and after surgery5. Several clinical studies have shown that opioid-free anesthesia is significantly associated with a lower incidence of respiratory complications and postoperative nausea and vomiting. Therefore, general anesthesia combined with Dexmedetomidine can be regarded as an opioid-free anesthesia strategy.
详细描述
Study protocol
All patients received target-controlled infusion (TCI) propofol (3-5 μg ml-1), 2% lidocaine 1.5 mg kg-1 and cisatracurium (0.15-0.2 mg kg-1) or rocuronium (0.6-1.0 mg kg-1).
During induction, the dexmedetomidine group received a loading dose of 0.5 µg kg-1 of dexmedetomidine for 10 minutes. Meanwhile, propofol TCI was started with target of bispectral index set between 40 and 60. After the loading dose was complete, tracheal intubation was performed without opioid analgesic. The following maintenance dose was set as 0.5 µg kg-1 h-1 until the specimen was excised and two-lung ventilation was performed. Dexmedetomidine was then stopped. In contrast, the conventional control group was administered an intermittent bolus dose of fentanyl (0.3-0.5 µg kg-1) to reduce stimuli before tracheal intubation.
In the maintenance phase, parecoxib (40 mg) or propacetamol (1 g) was given if indicated. Anaesthesia was maintained with TCI propofol, and the depth of anaesthesia was monitored using a bispectral index between 40 and 60. Fentanyl was used as a rescue analgesic during the operation. In both groups, when the patient's HR or mean arterial pressure (MAP) was >25% of the baseline, an intermittent bolus dose of 15-25 µg fentanyl was administered. At the end of surgery, patients received intercostal nerve block under thoracoscopy by surgeon.
Haemodynamic stabilisation was achieved in the following situations. If analgesic was administered but the MAP remained elevated at >25% of baseline, nicardipine was considered. If hypotension with MAP dropped >25% from baseline, ephedrine was considered. If bradycardia with HR dropped to <50, atropine was considered.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 20 years old and younger than 75 years old
- •Diagnosed as stage I-III non-small cell lung cancer
- •Received video-assisted thoracoscopic lung wedge resection or lobectomy
排除标准
- •Cardiac arrhythmia , such as sinus bradycardia, sinus tachycardia, or high-degree atrioventricular block
- •Diagnosed acute myocardial myocardial infarction, congestive heart failure, or stroke within one year
- •Patient have underwent coronary artery bypass graft
- •Allergy to drug such as Propofol, Sevoflurane, Dexmedetomidine, NSAID, Lidocaine)
研究组 & 干预措施
Total intravenous anesthesia (TIVA) + Dexmedetomidine
Total intravenous anesthetic drug is propofol. Dexmedetomidine is infused continuously.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The difference in the perioperative dosage of fentanyl between the two groups.
时间窗: up to post operation day one
The difference in the perioperative dosage of fentanyl between the two groups.
次要结局
- Postoperative pain scale(up to post operation day one)
- Perioperative hemodynamic parameters(up to post operation day one)
- Postoperative complications(up to post operation day one)
研究者
Kai Wei Hsieh
Principal Investigator
Kaohsiung Veterans General Hospital.
