Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- immediate maximum postoperative pain in recovery room defined by a score > 3 on a verbally administered numeric rating scale (NRS) variating from 0 to 10.
研究概览
简要总结
The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted perioperative analgesic strategy by the ANI over the usual practice on the incidence of immediate postoperative pain.
The investigators hypothesized that a prophylactic administration of morphine in patients with risk of postoperative pain determined by the ANI at the end of the intervention would reduce the incidence of immediate postoperative pain and that the targeted analgesia to ANI and minimal alveolar concentration (MAC) of desflurane could improve the perioperative hemodynamic, and the postoperative becoming.
详细描述
Visits:
-
The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator
-
will preselect potentially eligible patients
-
will offer to participate to this study
-
will give the notice form to the patients
-
will present the research: objectives, benefits and constraints for the patients
-
will check that patients understand the verbally administered Numeric Rating Scale (NRS) for the assessment of the postoperative This verbally administered NRS is routinely presented to all patients at a surgical intervention.
-
The intervention day (D0):
The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.
The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ Age <65 years old
- •Patient operated on a scheduled surgery under general anesthesia
- •Patient with a American Society of Anesthesiologists (ASA) score of I to III
- •Patient having given his consent in the manner described in Article L1122-1-1 of the Public Health Code
- •Patient affiliated with a social security regimen or beneficiary of such a regimen
排除标准
- •general anesthesia without extubating (laryngeal mask)
- •neuraxial preoperative regional anesthesia (epidural or rachianalgesia)
- •opioid-free anesthesia
- •preoperative peripheral nerve block with analgesic aim (infiltration of a local surgical anesthetic or transversus abdominis plane block-TAP block-authorized)
- •arrhythmia or the presence of a pacemaker
- •ambulatory surgery
- •cardiac or cerebral surgery
- •obstetrical surgery (caesarean)
- •surgery performed with neuraxial regional anesthesia or peripheral anesthesia alone
- •surgery performed in prone position
- •urgent surgery
- •endoscopic procedure or interventional radiology
- •chronic pain treated with opiates
- •expected surgery duration < 1h
- •pathology of the autonomic nervous system (epilepsy, history of transient attack or stroke, paraplegia, hemiplegia, orthostatic hypotension, autonomic dysfunction)
- •Patient with cardiogenic or septic shock
- •Continuous infusion of vasoactive agents (ephedrine, phenylephrine, adrenaline, or noradrenaline)
- •Postoperative transfer planned in intensive care unit (intubated patient) after surgery
- •Person under tutorship or curatorship
- •Pregnancy
- •Breastfeeding
研究组 & 干预措施
usual practice
control group (usual practice): patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance. The dosage of the anesthetic agent, as well as the prophylactic administration of morphine at the end of the intervention, will be decided by the anesthesiologist.
干预措施: Anesthesic agent guided by ANI (Interventional Group) (Drug)
usual practice
control group (usual practice): patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance. The dosage of the anesthetic agent, as well as the prophylactic administration of morphine at the end of the intervention, will be decided by the anesthesiologist.
干预措施: Administration of the lowest effective concentration of desflurane (Interventional Group) (Drug)
targeted analgesia to ANI
experimental group: patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance, as well as the prophylactic administration of morphine at the end of the intervention, will be administered according to the ANI.
- In addition, desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).
干预措施: Anesthesic agent guided by ANI (Interventional Group) (Drug)
targeted analgesia to ANI
experimental group: patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance, as well as the prophylactic administration of morphine at the end of the intervention, will be administered according to the ANI.
- In addition, desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).
干预措施: Administration of the lowest effective concentration of desflurane (Interventional Group) (Drug)
结局指标
主要结局
immediate maximum postoperative pain in recovery room defined by a score > 3 on a verbally administered numeric rating scale (NRS) variating from 0 to 10.
时间窗: From day 0 to day 28
Once the patient transferred to the recovery room, the assessment of the primary outcome (verbally administered NRS) will be done by the nurse responsible for the patient, when the patient arrives, during the stay and when the patient leaves the recovery room
次要结局
- postoperative nausea and vomiting in the recovery room(At day 1)
- incidence of postoperative complications on the first and seventh postoperative days for hospitalized patients using Post-Operative Morbidity Survey (POMS).(From day 0 to day 1 and until day 7)
- Mortality at Day 28(At day 28)
- total dose of morphine during the first postoperative day (mg)(At day 1)
- the duration in the recovery room (time to obtain an Aldrete score ≥9) (min)(From day 0 to day 28)
- duration of the hospitalization (day)(From day 0 to day 28)
- dose of morphine in the recovery room(At day 0)
- Maximum pain score during the first postoperative day (numeric rating scale variating from 0 to 10).(every 6 hours during the 24 first hours.)
- regional anesthesia for postoperative analgesic purposes(At day 1)
- destination of the patient after surgery (unit of surgery, continuous care, resuscitation).(From day 0 to day 28)
- Score Postoperative D1 Pain Management (numeric rating scale variating from 0 to 10)(At day 1)