Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine
详细描述
Opioid analgesics are commonly used in clinical practice for per and postoperative pain treatment. However their use is associated with a lot of undesirable effects. From this comes the idea of using opioid free anesthesia intra-operatively in an attempt to decrease opioids postoperative use and accordingly, their associated side effects.
Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and anti-inflammatory properties. It was found to significantly improve postoperative pain, when its intraoperative use was compared with placebo .
Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine, dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly, opioid related side effects.
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
- Triple (Participant, 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
- •Age group: 18-80 years old
- •American Society of Anesthesiologists (ASA )class I, II and III
- •Elective spine posterior instrumentation surgery of at least two levels.
排除标准
- •Renal, hepatic or cardiac insufficiency.
- •Alcohol or drug abuse.
- •Psychiatric disease.
- •Allergy or contraindication to any of the study drugs.
- •Inability to comprehend pain assessment or inability to use a Patient Controlled Analgesia (PCA) device.
研究组 & 干预措施
Opioid based Anesthesia
General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl , sevoflurane and nitrous oxide.
干预措施: opioid free Anesthesia vs Opioid based Anesthesia (Drug)
Opioid Free Anesthesia
-General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine , sevoflurane and nitrous oxide.
干预措施: opioid free Anesthesia vs Opioid based Anesthesia (Drug)
结局指标
主要结局
Postoperative morphine consumption
时间窗: 48 hours
After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented. Before discharge from the PACU, the patient will have a PCA (Patient Controlled Analgesia) morphine,All attempts and given values of morphine In mg obtained from the PCA machine will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours post surgery.. And the total amount of morphine in mg will be calculated for 48 hours
次要结局
- Postoperative morphine Side effects: Sedation score .(48 hours post operative.)
- Postoperative morphine Side effects:Respiratory depression(48 hours)
- Postoperative morphine Side effects: Nausea vomiting(48 hours)
- Postoperative morphine Side effects: Itching(48 hours)
- Postoperative pain score(48 hours post operative.)
研究者
Hanane Barakat
MD
Lebanese American University