跳至主要内容
临床试验/NCT03540875
NCT03540875终止不适用

Comparison Between Manual Versus Closed-loop Titration of Propofol and Remifentanil Guided by the qCon and qNox Indexes During Induction and Maintenance of General Anesthesia in Adult Patients: a Multicentre Randomized Controlled Study

CMC Ambroise Paré3 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年7月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
62
试验地点
3
主要终点
Adequate sedation

研究概览

简要总结

This study compares automated administration of propofol and remifentanil versus manual administration during general anesthesia for a surgery. The closed-loop coadministration of propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.

详细描述

Several monitors are currently proposed to evaluate the depth of hypnosis. The Conox monitor differentiates itself from the other brain monitor by calculating two EEG indexes, the qCon and the qNox. The qCon corresponds to the depth of the sedation and the qNox relates to the probability that a nociceptive stimulation triggers a movement of the patient. A controller allowing the automated titration of propofol guided by the qCon and remifentanil guided by the qNox has been developed. In preparation for a large multi-center control trial, this prospective randomized study evaluates the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one arm in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion (TCI) systems, and the second arm in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain qCon between 40 and 60, the recommended range during anesthesia by the manufacturer. It is expected the combined closed-loop anesthesia system group to do similar or better control to maintain the qCon in the desired range.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled surgery for at least one hour
  • Consent for participation
  • Affiliation to the social security system

排除标准

  • Pregnant or breastfeeding women
  • Patients for which Conox monitor should not be used
  • Allergies to propofol or remifentanil

研究组 & 干预措施

Full automation group

Experimental

Full automation control of propofol and remifentanil

干预措施: Closed loop anesthesia (Device)

Full automation group

Experimental

Full automation control of propofol and remifentanil

干预措施: Propofol (Drug)

Full automation group

Experimental

Full automation control of propofol and remifentanil

干预措施: Remifentanil (Drug)

Control group

Other

Manual control of of propofol and remifentanil using TCI system

干预措施: Propofol (Drug)

Control group

Other

Manual control of of propofol and remifentanil using TCI system

干预措施: Remifentanil (Drug)

结局指标

主要结局

Adequate sedation

时间窗: Start of general anesthesia maintenance, i.e. qCon below 60 for 30 consecutive seconds for the first time, until the end of propofol et remifentanil infusion

Percentage of time with qCon index within the 40-60 range as recommended by the manufacturer of Conox monitor. Data from the Conox monitor (signal quality index, qCon index, qNox index, Suppression ratio) are recorded every second.

次要结局

  • Dose of analgesic drug(Intraoperative period)
  • Explicit memorization(48 hours)
  • Adequate analgesia(Start of general anesthesia maintenance, i.e. qNox below 60 for 30 consecutive seconds for the first time, until the end of propofol et remifentanil infusion)
  • Delay before awakening(12 hours)
  • Occurrence of Burst Suppression Ratio (bsr)(Intraoperative period)
  • Dose of hypnotic drug(Intraoperative period)
  • Medical interventions on the dosage of drugs(Intraoperative period)
  • Hemodynamic status(Intraoperative period)
  • Fluid therapy(Intraoperative period)

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (3)

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