Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- normalized remifentanil administration
研究概览
简要总结
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.
详细描述
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia.
- inclusion: ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery in a Burn Center (University Hospital of Lille, France)
- arm 1 : Remifentanil will be automatically administered by an expert system guided by heart rate, blood pressure and the Analgesia Nociception Index (ANI).
- arm 2 : Remifentanil will be administered by a target controlled device using the Minto pK/pD model.
- propofol is administered throughout the procedure with a target controlled device using the pK/pD model of Schnider. The target will be guided by the BiSpectral index values.
- primary endpoint : overall normalized remifentanil administration.
- secondary endpoints : relative amount of time spent in a state of hemodynamic reactivity ; relative amount of time the ANI spends in the [0-50], [50-70] and [70-100] windows ; relative amount of time the BIS spends in the [0-40], [40-60] and [60-100] ; hemodynamic status at various times during anesthesia ; total amount of target modifications of remifentanil and propofol ; total amount of morphine administered in PACU ; total amount of ketamine administered in PACU ; incidence of nausea/vomiting in PACU ;
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille
排除标准
- •BMI outside [17 - 35 kg/m2]
- •pregnancy or breast feeding women
- •non sinus cardiac rhythm
- •documented dysautonomia
- •complicated diabetes mellitus
- •known allergy to a drug used in the clinical trial
研究组 & 干预措施
std_practice
arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France.
干预措施: remifentanil pK/pD target administration device (Device)
ANI-loop
arm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France)
干预措施: ANI-REMI-loop (Device)
std_practice
arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France.
干预措施: ANI monitor (Device)
ANI-loop
arm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France)
干预措施: Propofol (Drug)
ANI-loop
arm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France)
干预措施: Remifentanil (Drug)
std_practice
arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France.
干预措施: Remifentanil (Drug)
std_practice
arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France.
干预措施: Propofol (Drug)
结局指标
主要结局
normalized remifentanil administration
时间窗: During the surgery, an average Three hours and a half
ratio of total amount of administered remifentanil with body weight and duration of administration
次要结局
- total administered ephedrine(duration of general anesthesia)
- hemodynamic reactivity or bradycardia or hypotension(During the surgery, an average Three hours and a half)
- Analgesia Nociception Index (ANI)(During the surgery, an average Three hours and a half)
- remi target changes(During the surgery, an average Three hours and a half)
- propofol target changes(During the surgery, an average Three hours and a half)
- ANI-REMI-loop switch to manual(During the surgery, an average Three hours and a half)
- Pain in PACU(During the first two postoperative hours)
- ketamine in PACU(During the first two postoperative hours)
- nausea/vomiting in PACU(During the first two postoperative hours)
- Bispectral Index (BIS)(During the surgery, an average Three hours and a half)
- Change antinociception/nociception balance status(5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception)
- morphine in PACU(During the first two postoperative hours)
- normalized propofol administration(During the surgery, an average Three hours and a half)