Predicted Level of General Anaesthesia in Hip Fracture Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of time spent in the "appropriate anaesthesia zone"
研究概览
简要总结
The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing hip fracture surgery under general anaesthesia
- •Age ≥ 18 years old
- •ASA classification 1, 2 or 3
排除标准
- •Patient not insured by a social security scheme
- •Adult patient under tutorship or curatorship
- •Age over 18 years old or under 90 years old
- •Weight under 40 or over 140 kilos and/or height under 150 or over 200 cm
- •Body mass index > 35
- •Contraindication to one or more anaesthetics used in the study
- •Pregnancy or breastfeeding
- •Unweaned alcoholism
- •ASA classification 4 or 5
- •Patient undergoing hip fracture surgery under spinal anaesthesia
研究组 & 干预措施
Smartpilot View group
General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.
干预措施: General anesthesia managed by the Smartpilot® View (Device)
Control group
General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.
干预措施: General anesthesia managed without the Smartpilot® View (Device)
结局指标
主要结局
Percentage of time spent in the "appropriate anaesthesia zone"
时间窗: participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery
The "appropriate anaesthesia zone" is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg
次要结局
- Dose of propofol(participants will be followed for the duration anesthesia, an expected average of 5 hours)
- Incidence of awareness with recall during anaesthesia(postoperative day 1)
- "Postoperative Quality Recovery Scale"(during recovery room (an expected average of 24 hours) and postoperative days 1 and 3)
- Length of stay(postoperative day 30)
- Mortality(postoperative day 30)
- Morphine consumption(participants will be followed for the duration in recovery room, an expected average of 24 hours)
- Time to extubation(end of anaesthesia)
- Dose of sufentanil(participants will be followed for the duration anesthesia, an expected average of 5 hours)
- "NASA Task Load Index"(participants will be followed for the duration anesthesia, an expected average of 5 hours)