Postoperative Sedation After Cardiac Surgery : Comparison Between Manual Administration and Automated Sedation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Adequate sedation
研究概览
简要总结
This study compares automated administration of propofol and remifentanil guided by the Bispectral index (BIS) versus manual administration for sedation after cardiac surgery.
详细描述
Automated sedation has the potential to improve patient care after cardiac surgery by adjusting drug doses to the minimum required for efficacy. Indeed, automated and continuous titration may avoid overdosing, improve hemodynamic stability and also decrease the mean time to tracheal extubation.
Medsteer SAS developed a controller, EasyTiva device, allowing the closed-loop coadministration of propofol and remifentanil, guided by a Bispectral Index (BIS) monitor.
Automated sedation is so facilitated by the BIS which permits continuous monitoring of electrocortical activity.
This randomized monocentric trial compares the automated administration with manual intravenous administration of propofol-remifentanil for maintaining adequate depth of hypnosis (BIS 55-75) during sedation after cardiac surgery.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgical procedure requiring postoperative sedation
- •Low operative risk : EuroSCORE 2 ≤ 5%
- •Consent for participation
- •Affiliation to the social security system
排除标准
- •Pregnant or breastfeeding women
- •Neurological or muscular disorder
- •Pacemaker
- •Hypersensitivity to propofol or remifentanil
- •Communication difficulties or neuropsychiatric disorder
研究组 & 干预措施
Manual postoperative sedation
Manual administration of Propofol and Remifentanil.
干预措施: Remifentanil (Drug)
Automated postoperative sedation
Automated administration of Propofol and Remifentanil.
干预措施: EasyTiva (algorithm is the property of Medsteer SAS) (Device)
Automated postoperative sedation
Automated administration of Propofol and Remifentanil.
干预措施: Propofol (Drug)
Automated postoperative sedation
Automated administration of Propofol and Remifentanil.
干预措施: Remifentanil (Drug)
Manual postoperative sedation
Manual administration of Propofol and Remifentanil.
干预措施: Propofol (Drug)
结局指标
主要结局
Adequate sedation
时间窗: 6 hours
Percentage of time with BIS between 55 and 75 (BIS(55-75))
次要结局
- Level of sedation(6 hours)
- Dose of hypnotic drug(6 hours)
- Awareness during the sedation period(48 hours)
- Period of too light sedation(6 hours)
- Level of pain after extubation(9 hours)
- Period of too deep sedation(6 hours)
- Level of pain during sedation(6 hours)
- Incidence of Burst Suppression (bsr) during sedation(6 hours)
- Medical interventions(6 hours)
- Sedation time(6 hours)
- Delay before awakening(6 hours)
- Dose of analgesic drug(6 hours)
- Level of consciousness after extubation(9 hours)
- Hemodynamic status during the sedation period(6 hours)