Impact of the Automated Administration of Intravenous Anesthesia Compared to Inhalatory Anesthesia on the Speed of Emergence and the Occurrence of Postoperative Delirium
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia
研究概览
简要总结
The intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia.
详细描述
Scientific background Postoperative delirium (POD) is a common complication occurring in 5 to 50 % of elderly patients following an operation. Delirium is a serious complication leading to many medical as well as social and economical consequences. Several studies suggest that, both, the choice of anesthetic agents and the conduction of anesthesia might decrease the incidence of POD.
Objectives Study goal and primary aim: the intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of POD, compared with an inhalational anesthesia.
The primary aim of the present study (i.e. incidence of POD) will be assessed by the Nursing Delirium Screening Scale (NDSS).
Secondary aims:
Secondary aim 1: Assessment of a potential difference on the incidence of PONV between the 2 groups of patients (i.e. intravenous vs. inhaled) by comparison of the number of episodes of nausea and vomiting and the need to treat this complications, between both groups.
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, Care Provider)
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
- •age > 59 year
- •Informed written consent before enrolment;
- •Procedure duration > 60 min.
- •Speaking French
- •Possible contact one-month following surgery
排除标准
- •Contraindication of brain monitoring (intracranial surgery), pace-maker.
- •Propofol or remifentanil allergy.
- •Patients under guardianship
研究组 & 干预措施
Intravenous group
Propofol & remifentanil administration using the closed-loop controller with the "Easy-TIVA" platfrom.
干预措施: Propofol (Drug)
Intravenous group
Propofol & remifentanil administration using the closed-loop controller with the "Easy-TIVA" platfrom.
干预措施: Remifentanil automatic (Drug)
volatile anesthesia group
Sevoflurane will be administered manually according to the BIS values. Remifentanil will be administered manually using a Target Controlled Infusion pump using the Minto model.
干预措施: Sevoflurane (Drug)
volatile anesthesia group
Sevoflurane will be administered manually according to the BIS values. Remifentanil will be administered manually using a Target Controlled Infusion pump using the Minto model.
干预措施: Remifentanil manual (Drug)
结局指标
主要结局
Comparison of the Nurse Delirium Screening Scale in the early postoperative period between intravenous vs halogenated general anesthesia
时间窗: Measure of the Nurse Delirium Screening Scale, up to an estimated maximum of 3 hours postoperatively
occurrence of POD as measured by the Nursing Delirium Screening Scale The Nursing Delirium Scale Symptom Symptom rating Disorientation 0 points 1 point 2 points Inappropriate behavior 0 points 1 point 2 points Inappropriate communication 0 points 1 point 2 points Illusion/hallucination 0 points 1 point 2 points Psychomotot retardation 0 points 1 point 2 points Total score ≤ 2 points \> 2 points Delirium No Yes
次要结局
未报告次要终点