Effect of Opioid-free Anesthesia on Postoperative Opioid-related Adverse Events After Major or Intermediate Non-cardiac Surgery: a Multicenter Prospective Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 316
- 试验地点
- 11
- 主要终点
- Occurence of a severe postoperative opioid-related adverse event defined as : postoperative hypoxemia or postoperative ileus (POI) or postoperative cognitive dysfunction (POCD).
研究概览
简要总结
Since the 1960's, intraoperative administration of opioids is considered a keystone of anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anesthesia has changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids. Moreover, opioid administration consequences are neither scarce nor benign for the patient. Perioperative opioids are associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory depression, increased postoperative pain and morphine consumption, immunodepression, hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and confusion/delirium are the most frequent.
Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and postoperative opioid requirements, and subsequently, opioid-related adverse effects and to fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10 years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be achieved without opioids during anesthesia. OFA is multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and alpha-2 agonists (Dexmedetomidine).
Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid consumption during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing a scheduled major or intermediate non-cardiac surgery,
- •Benefiting from the health insurance system,
- •Having signed an informed consent.
排除标准
- •Pregnant or breast feeding women,
- •Allergy to dexmedetomidine or one of its excipients,
- •Allergy to one of the drugs used for anesthesia or one of their excipients,
- •Urgent surgery,
- •Intracranial surgery,
- •Transplant surgery or transplanted patients,
- •Surgery with planned regional anesthesia,
- •Outpatient surgery,
- •Atrioventricular block, intraventricular or sinoatrial block,
- •Treatment by chronic betablockers and HR < 50 bpm,
- •Heart failure with LVEF < 40%,
- •Adam-Stokes syndrome,
- •Epilepsy or seizures,
- •Uncontrolled hypotension,
- •Acute cerebral pathology,
- •Obstructive sleep apnea syndrome,
- •Severe hepatic insufficiency (Prothrombin Ratio < 15%),
- •Patients in whom the CAM-ICU cannot be performed (deaf patients for example)
- •Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
研究组 & 干预措施
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Control
干预措施: Remifentanil (Drug)
结局指标
主要结局
Occurence of a severe postoperative opioid-related adverse event defined as : postoperative hypoxemia or postoperative ileus (POI) or postoperative cognitive dysfunction (POCD).
时间窗: Within the first 48 hours after extubation
Postoperative hypoxemia is defined as an oxygen saturation (SpO2) \< 95% with a need for oxygen supplementation within the first 48h after extubation; the duration of oxygen treatment will also be recorded. Postoperative ileus is defined as an absence of flatus or stools within the first 48h after extubation. Postoperative cognitive dysfunction will be evaluated using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) by a care provider (either anesthesiologist or nurse).
次要结局
- Number of bradycardia, hypotension and hypertension events during surgery and number of rescue medications during surgery(During surgery (maximum duration of 7 hours))
- Time between the end of remifentanil or dexmedetomidine administration and an Aldrete score > 9 (when applicable)(Within 48 hours after extubation)
- Number of postoperative nausea and vomiting (PONV) episodes(During the 48 hours following extubation)
- Time between the end of remifentanil or dexmedetomidine administration and extubation(Hour 0 = extubation)
- Number of episodes of postoperative pain (numeric rating scale ≥ 3), at rest(Within 48 hours after extubation)
- Opioid consumption(During the 48 hours following extubation)
- Rate of unscheduled admission in intensive care unit(Within 48 hours after extubation)
- Hospital length of stay (max 28 days) defined as the number of days after extubation before first hospital discharge(Day 28)