Optimization of Morphinomimetic Administration Intraoperatively: Evaluation of the Impact of the NOL Index on the Occurrence of Postoperative Adverse Events Related to Morphinomimetics: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 332
- 试验地点
- 6
- 主要终点
- Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus.
研究概览
简要总结
Reducing the quantity of morphinomimetics during the operative period reduces the prevalence and intensity of adverse effects.
However, morphinomimetics are indispensable during surgery, as they limit the autonomic nervous system's deleterious reactions to nociception. The administration of these drugs in intravenous boluses during surgery is usually guided by their duration of action and by variations in heart rate and blood pressure. Other events, such as hypovolemia or extreme surgical position, may stimulate the autonomic nervous system outside of nociception. These events, along with routine drug administration, can lead to undue consumption of morphinomimetics.
The Nol index, a multiparametric monitor of nociception, is based on analysis of variations in plethysmography waveform, heart rate and skin conductance. It has been demonstrated that the use of this type of monitor can reduce intraoperative consumption of morphinomimetics and optimize their administration. Does intraoperative morphinomimetic administration optimized by the NOL index have an impact on the occurrence of dose-dependent adverse effects?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female
- •Subject aged ≥ 18 years
- •Affiliated with a social security scheme
- •Having given written informed consent to participate study
- •Admitted for major surgery expected to last more than 2 hours
- •Under general anesthesia with tracheal intubation
- •For a planned hospital stay of at least 48 hours
- •Participant's ability to understand the nature and objectives of the study to comply with study requirements.
排除标准
- •Contraindication to one of the drugs used for anesthesia
- •Urgent surgery
- •Intracranial surgery
- •Transplant surgery
- •Cardiac surgery
- •Surgery with scheduled local anesthesia
- •Patient requiring postoperative intubation
- •Neuromuscular disease
- •Patient chronically using morphinomimetics
- •Chronic pain patient
- •Patients with a history of sleep apnea
- •Conditions likely to interfere with photoplethysmograph signal acquisition or skin conductance (excessive or tremors of the extremities, skin lesions or burns)
- •Patients wearing false nails and/or nail polish
- •Contraindication to the use of the PMD 200 ™ medical device (including cardiovascular resuscitation and cardioversion/defibrillation);
- •Patient with an implanted pacemaker or defibrillator
- •Treatment with β-blockers
- •Preoperative cardiac arrhythmia
- •Pregnant or breast-feeding women. A β-HCG test will be systematically performed prior to inclusion of non-menopausal women menopausal women
- •Patients under legal protection (safeguard of justice, curatorship guardianship) or deprived of liberty
- •Participation in other interventional research involving an experimental drug or medical device.
研究组 & 干预措施
Group NOL
Morphinomimetics will be administered according to NOL Index values.
干预措施: Nol index (Procedure)
Group control
Morphinomimetics will be administered according to the usual criteria.
结局指标
主要结局
Composite outcome including at least one occurrence of hypoxemia, of nausea-vomiting or of ileus.
时间窗: From enrollment to within 48 hours post-extubation.
1. occurrence of hypoxemia: at least 1 episode of SpO2 \< 95%, 2. occurrence of nausea-vomiting: at least one episode of nausea requiring antiemetic treatment, or at least one episode of vomiting, 3. occurrence of ileus: absence of gas or stool.
次要结局
- Number of episodes of hypoxemia(From intervention to 48 hours post-extubation)
- Number of episodes of nausea and vomiting(From intervention to 48 hours post-extubation)
- Occurrence of ileus(From enrollment to 48 hours post-extubation)
- Total consumption of intraoperative morphinomimetics(From intervention to 48 hours after extubation)
- Total consumption of intraoperative vasoconstrictors(From induction to extubation, up to 8 hours)
- Time of extubation(From the end of anesthesia administration to extubation, up to 1 hours)
- Number of episodes of pain(From extubation to 48 hours postoperative.)
- Time from extubation to theoretical post-anesthesia care unit discharge time with Aldrete score at 10(From extubation to Aldrete score at 10, every 5 minutes, up to 2 hours)
- Maximum intensity of pain(From extubation to 48 hours postoperative)
- Hospital stay length(From admission to hospital discharge up to 1 month.)
- Quality of post-operative recovery(From enrollment to 24 hours and 48 hours after chirurgical intervention)
- Intensity of chronic pain(At 3 months, at 6 months and at 12 months (end of the study))
- Occurrence of hypoxemia(From enrollment to 48 hours post-extubation)
- Occurrence of nausea-vomiting(From enrollment to 48 hours post-extubation)