Can Patients Who Have Undergone a Digestive Endoscopy Under Deep Sedation Drive Their Vehicle as Soon as a Post-Anesthetic Discharge Scoring System (PADDS) Equal to 9 is Obtained ?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of collisions
研究概览
简要总结
Many drugs used during anesthesia can reduce alertness and therefore present potential risks when driving a vehicle (risk of accident). Some scientific societies recommend not driving for 12 to 24 hours after sedation or general anesthesia. However, there are conflicting data in the literature showing that general anesthesia in healthy volunteers does not impair driving ability as early as 2 hours after the end of anesthesia.
This need not to drive requires the outpatient to have an escort. Unfortunately, some patients find it difficult to benefit from an adult escort, which can lead to last minute cancellations, absences or the need for a classic overnight hospital stay.
The main objective of the study is to compare with a simulator the driving performances of patients who have benefited from deep sedation for an outpatient endoscopic digestive procedure when they have met the discharge criteria to the performances of their escorts in order to determine if the conditions are as safe to let them drive home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of a driver license
排除标准
- •Unavailabilty of the escort for the duration of the examination
- •No driving for the past 5 years
- •Refusal of participation
研究组 & 干预措施
Patients
Deep sedation for digestive endoscopy.
干预措施: Propofol (Drug)
Escorts
Accompanying persons are the adults who accompany the patients home. They do not receive any medication or intervention.
干预措施: No sedation (Procedure)
结局指标
主要结局
Number of collisions
时间窗: until the end of the driving test, an average of 1 hour.
Number of times over the speed limit
时间窗: until the end of the driving test, an average of 1 hour.
Number of crossings of the median line
时间窗: until the end of the driving test, an average of 1 hour.
Percentage of distance out of traffic lane
时间窗: until the end of the driving test, an average of 1 hour.
Number of stops at traffic lights
时间窗: until the end of the driving test, an average of 1 hour.
Number of collisions with a pedestrian
时间窗: until the end of the driving test, an average of 1 hour.
Percentage of speeding time
时间窗: until the end of the driving test, an average of 1 hour.
Number of speeding ticket
时间窗: until the end of the driving test, an average of 1 hour.
Number of passages on the shoulder
时间窗: until the end of the driving test, an average of 1 hour.
Percentage of time out of traffic lane
时间窗: until the end of the driving test, an average of 1 hour.
Percentage of speeding distance
时间窗: until the end of the driving test, an average of 1 hour.
Number of broken stops
时间窗: until the end of the driving test, an average of 1 hour.
Travel time
时间窗: until the end of the driving test, an average of 1 hour.
Number of traffic light ticket
时间窗: until the end of the driving test, an average of 1 hour.
次要结局
- Karolinska Sleepiness Scale (KSS)(Within 10 minutes after driving test with simulator)
- STOP-Bang questionnaire (Snoring, Tired, Observed, Pressure, Body Mass index > 35, Age, Neck size, Gender)(Within 30 minutes before driving test with simulator)
- Beck II Depression inventory score (BDI-II)(Within 30 minutes before driving test with simulator)
研究者
Claude Hallet
Principal investigator
University of Liege