跳至主要内容
临床试验/NCT02145585
NCT02145585已完成不适用

Completely Automated Robotic Pharmacological Anesthesia System for Patients Undergoing Elective Cardiac Surgery: a Pilot Study

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Performance of closed-loop system for propofol administration defined as the efficacy to maintain Bispectral Index (BIS) as close to the target of 45 as possible.

研究概览

简要总结

Closed loop systems for anaesthesia have been shown to be more efficient than manual administration and than Target Control Infusion systems (TCI). So far, there is only one single-center study demonstrating that a system using simultaneously three closed loops for each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe and is more efficient than manual administration of anaesthetic drugs. Although the results of this study are very encouraging, they are limited by its sample of patients recruited for non-cardiac surgery only.

The hypothesis of the present trial is that cardiac anesthesia using a completely automated anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia and muscle relaxation) is feasible, safe and reliable.

Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.

Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).

A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be determined clinically by recording the % of sedation time during which the actual BIS is within 10% of the target BIS (excellent control), within 11 -20% (good control), between 21-30% (fair control) and beyond 30% of target (inadequate control).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Elective patients
  • Patients scheduled to receive an extracorporeal circulation
  • Patients aged 18 and older

排除标准

  • Unable to provide informed consent
  • Comatose patients
  • Patients with dementia
  • Patient who underwent neurosurgery
  • Pregnant women
  • Patient with muscle disease
  • Allergy to Propofol and/or remifentanil

结局指标

主要结局

Performance of closed-loop system for propofol administration defined as the efficacy to maintain Bispectral Index (BIS) as close to the target of 45 as possible.

时间窗: at inclusion (day 0)

Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Robotic Pharmacological Anesthesia System for... | 临床试验