Impact of Dexmedetomidine and Ketamine and Their Combination for the Reduction of Postoperative Morphine Requirements After VATS Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Day 1 Postoperative morphine requirement
研究概览
简要总结
Postoperative pain after VATS surgery is significant and associated with moderate to high post operative morphine requirements, which can cause opioid related side effects and delay postoperative recovery. To reduce this requirement, multimodal analgesia with non opioid medication such as dexmedetomidine and ketamine can be used. These drugs have demonstrated significant opioid-sparing properties after various types of surgeries. However, very little is known about their ability to do so in VATS surgery. Also, their relative opioid-sparing properties have not been compared, and it is not known whether their combined use can lead to an additional opioid-sparing effect. The primary goal of this study will be to determine the impact of a combined intra operative infusion of ketamine and dexmedetomidine on postoperative morphine requirements in patients undergoing elective VATS, compared to both these drugs infused separately.
The hypothesis is that this combined infusion will lead to a 30% further reduction in morphine requirements, 24h after surgery, compared to both these drugs infused separately.
详细描述
Video-assisted thoracic surgery (VATS) for pulmonary resection is associated with less tissue trauma, less impairment in lung function, and reduced postoperative pain compared with thoracotomy, although many patients continue to report significant acute postoperative pain. If not well-controlled, postoperative thoracic pain can lead to splinting and inadequate recovery of pulmonary function.
Enhancing the quality of postoperative analgesia while reducing intra and postoperative opioid requirements is an important issue that has been one of the main focus of Enhanced Recovery After Surgery (ERAS) protocols. Indeed, the key factors that delay postoperative recovery include parenteral opioids and bed rest and immobility secondary to postoperative pain. While opioids are effective at treating even severe pain, their use is associated with dose-related adverse effects such as respiratory depression, sedation, postoperative nausea and vomiting, urinary retention, ileus, opioid-induced hyperalgesia and chronic postoperative pain. More importantly, opioids depress host immunity and neuroendocrine function and may negatively affect cancer recurrence and survival after lung cancer surgery.
Hence, given the importance of good postoperative analgesia and the significance of opioid-related adverse effects, the reduction of opioid requirements and postoperative pain through multimodal analgesia is an important matter. Focusing on this goal, the ERAS protocols have shown great efficacy in improving patient's care after colorectal surgery and they are now being applied to pancreatic, ENT, bariatric, urologic and many more major surgeries.
It is probably only a matter of time before ERAS protocols are applied to VATS surgery; however, the optimal way of providing postoperative analgesia after VATS has not yet been determined, unlike colorectal surgery. Indeed, thoracic epidural analgesia, single-shot and continuous paravertebral and intercostal nerve blocks and patient-controlled intravenous analgesia have all been evaluated, and none of these has consistently emerged as being superior to the others or to intravenous analgesia. Thoracic epidural analgesia provides effective pain control for thoracotomy but its benefits following thoracoscopy are not uniform. Furthermore, the risks of sympathectomy-induced hypotension and neurologic injury from epidural hematoma may not be justified considering the lesser postoperative pain and impairment in pulmonary function compared to thoracotomy. Continuous paravertebral blocks are an effective alternative to epidural analgesia although their performance may be challenging and time consuming, and catheters may be difficult to thread or get accidentally removed, leading to block failure. Furthermore, as for epidural analgesia, paravertebral catheter placement is contra-indicated in patients with impaired coagulation and/or infection. Single-shot intercostal and paravertebral blocks are less invasive although their benefit is restricted to the first twelve postoperative hours.
Moreover, none of these regional anesthesia techniques can treat the ipsilateral shoulder pain that is often associated with VATS, and opioid analgesia might still be required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years old
- •American Society of Anesthesiology physical status I-III
- •Elective Video-Assisted Thoracic Surgery for pulmonary resection
排除标准
- •Patients for which a regional anesthesia technique is planned for postoperative analgesia.
- •Patients taking beta-blockers preoperatively.
- •Patients with chronic pain taking >60 mg morphine PO daily (or its equivalent).
- •Patients taking pregabalin, gabapentin, amitryptillin, nortryptillin and/or duloxetin.
- •Documented allergy to ketamine and/or dexmedetomidine.
- •Pregnancy
- •Inability to give informed consent
- •Linguistic barrier.
- •Patient refusal
研究组 & 干预措施
Ketamine hydrochloride
Intraoperative bolus (0.25 mg/kg) and infusion (0.25mg/kg/h) of ketamine plus an intraoperative bolus (over 20 min) and infusion of normal saline;
干预措施: Ketamine Hydrochloride (Drug)
dexmedetomidine hydrochloride
Intraoperative bolus (1µg/kg over 20 min) and infusion (0.5µg/kg/h) of dexmedetomidine plus an intraoperative bolus and infusion of normal saline
干预措施: Dexmedetomidine Hydrochloride (Drug)
dexmedetomidine hydrochloride and ketamine hydrochloride
Intraoperative bolus (1µg/kg over 20 min) and infusion (0.5 µg/g/h) of dexmedetomidine plus an intraoperative bolus (0.25mg/kg) and infusion (0.25mg/kg/h) of ketamine
干预措施: dexmedetomidine Hydrochloride and Ketamine Hydrochloride (Combination Product)
结局指标
主要结局
Day 1 Postoperative morphine requirement
时间窗: Day 1
Cumulative dose of morphine used by the patient
次要结局
- intraoperative fentanyl requirement(for incision to wound closure)
- day 2 Postoperativve morphine requirement(day 2)
- Pain score at rest 24h(day 1)
- Pain score at rest 48h(day 2)
- Pain score at cough 24h(day 1)
- Pain score at cough 48h(day 2)
- chronic postoperative pain(3 months)
- chest tube removal(1 week)
研究者
Veronique Brulotte
Dr
Maisonneuve-Rosemont Hospital
