Effect of Dexmedetomidine vs 0.9% Sodium Chloride on Nol-Index Guided Remifentanil Analgesia: a Double-blinded Bicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic
研究概览
简要总结
Background:
Analgesia remains to this day a challenge for anesthesiologists. Dexmedetomidine, a potent central alpha-2 agonist, has been shown to have analgesic and opioid sparing effects. The classic analgesic strategy focuses on opioid administration guided by estimated time of elimination and hemodynamic response (increase in blood pressure and heart rate). This technique is not sensitive and forces the anesthesiologist to be one step behind nociception, the patient's unconscious response to pain.
PMD-200 (Medasense, Israel) displays the Nociceptive level (NOL)-Index as marker of nociception. The NOL-Index ranges from 0 (no nociception) to 100 (intense nociception) and the recommended analgesic range during surgery is from 10 to 25 (Medasense recommendations).
The goal of this study is to compare two analgesia strategies guided by the NOL Index (range 10-25) using either remifentanil TCI (target controlled infusion) alone or remifentanil TCI associated with a continuous dexmedetomidine infusion.
Methods:
A total of 100 patients will be included and informed consent will be acquired. This bi-center study will take place at Erasme University Hospital (primary center) and Saint-Pierre University Hospital. Patients will be randomized into either two groups: remifentanil and placebo versus remifentanil and dexmedetomidine. Both groups will be monitored using the PMD-200 that will guide the analgesic therapy strategy. Investigators and patients will be blinded to dexmedetomidine and placebo administration. The primary outcome will be intraoperative remifentanil consumption. Secondary outcomes will include postoperative opioid administration, opioid associated complications, hemodynamics, and hospital length of stay.
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
- 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
- •American Society of Anesthesiologists (ASA) grades 1-2 undergoing scheduled stomatological, cervical, and thyroid surgery anticipated to last at least two hours
排除标准
- •ASA score >2
- •Preoperative organ dysfunction
- •Patients with non-regular cardiac rhythm
- •Implanted pacemakers
- •Emergent surgery
- •Pregnancy or lactation
- •Allergy or intolerance to any of the study drugs
- •Participation in another interventional study
- •Patient refusal
研究组 & 干预措施
Remifentanil Analgesia
Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride
干预措施: sodium chloride (Drug)
Remifentanil Analgesia
Continuous intraoperative analgesia with remifenanil + 0.9% sodium chloride
干预措施: Remifentanil (Drug)
Remifentanil and Dexmedetomidine Analgesia
Continuous intraoperative analgesia with remifenanil + dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Remifentanil and Dexmedetomidine Analgesia
Continuous intraoperative analgesia with remifenanil + dexmedetomidine
干预措施: Remifentanil (Drug)
结局指标
主要结局
Remifentanil consumption measured as the amount (µg) of remifentanil administered during the anesthestic
时间窗: 6 hours
Intraoperative remifentanil consumption
次要结局
- Hospital LOS(28 days)
- Propofol Consumption measured as the amount of propofol (mg) administered during the anesthestic(6 hours)
- Time to extubation(6 hours)
- Number of patients with intraoperative hypotension(6 hours)
- Postoperative morphine consumption(24 hours)
- Number of patients with postoperative opioid-related side effect (composite and individual complications)(72 hours)
- Net fluid balance(6 hours)
- Use of hypotensive drugs(6 hours)
- Intraoperative heart rate(6 hours)
- Use of vasoactive drugs(6 hours)
- Intraoperative blood pressure(6 hours)
- Intraoperative remifentanil target cite concentration(6 hours)
- Number of patients with intraoperative hypertension(6 hours)
- Number of patients with hemodynamic instability(6 hours)
- Intraoperative Nol-Index(6 hours)
- PACU length of stay (LOS)(48 hours)