Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 10
- 主要终点
- Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
研究概览
简要总结
The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
详细描述
The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint is: lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •laparoscopic cholecystectomy or gynecological laparoscopic surgery
- •ASA I or II
- •adult patient
- •body mass index between 17 and 33 kg/m2
排除标准
- •pregnancy
- •arrhythmia
- •pace maker
- •diabetes mellitus
- •dysautonomia
- •treatment with beta blocking agents
研究组 & 干预措施
ANI guided remifentanil arm
remifentanil targets are increased or decreased depending on ANI readings. In case of high blood pressure associated with elevated ANI, nicardipine is administered.
干预措施: ANI guided remifentanil (Procedure)
ANI blind arm
remifentanil target is adapted as is usual during general anesthesia, depending on hemodynamic reactions to nociceptive surgical stimulations. In case of elevated blood pressure despite a maximum target of 10 ng/ml (Minto Pk/pD model), then nicardipine is administered.
干预措施: ANI blind arm (Procedure)
结局指标
主要结局
Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
时间窗: end of surgery (around 60 to 90 min after start)
次要结局
- total administered remifentanil(end of surgery)
- number of target changes(end of surgery (around 60 to 90 min after start))
- morphine sulfate total administration after end of surgery(during two hours after end of surgery)
- Visual Analog Scale evaluation of pain after surgery(during two hours after end of surgery)
- number of bradycardia and hypotension(from start to end of surgery (around 60 to 90 min ))
- ANI measure during surgery(from start to end of surgery (around 60 to 90 min))
- total administered dose of ephedrine(between start and end of anesthesia)