Pupilometric Evaluation of Nociception in Patients With Orthopedic Impairment Under Procedural Sedation With Propofol in the Context of the Use of the ALGISCAN Device in the Vital Emergency Department in Pasteur 2 Hospital, Nice France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- pupil dilation reflex
研究概览
简要总结
Procedural sedation involves the administration of sedative medications that allow patients to tolerate painful procedures. Procedural sedation has been formally recommended by experts from the French Society of Emergency Medicine (SFMU) since 2010 and procedural sedation using propofol in emergency departments has been recommended by the American College of Emergency Physicians in 2018.
Propofol monotherapy is now widely used in emergency medicine (EM) in France as part of procedural sedation for performing painful procedures, however propofol has no analgesic properties per se .
Pupilometry makes it possible to study the depth of analgesia by evaluating the body's nociceptive response via the ANS by studying the pupil diameter.
This technique would allow the evaluation of the analgesia level in patients sedated by PROPOFOL during the realization of painful procedures. Variations in pupil diameter during painful procedures under procedural sedation in an emergency department will be assesed in this study. Secondly, patients satisfaction following the procedure will also be evaluated by the use of the French version of the "ISAS-F", the Iowa Satisfaction with Anesthesia Scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Adult patients
- •patient admitted at vital emergency room,
- •patient with an orthopedic trauma,
- •patient under procedural sedation with PROPOFOL.
排除标准
- •Patient's refusal of pupilometry measurement.
- •Pre-existing pupil abnormalities.
- •history of pathologies with dysautonomic impairment (advanced diabetes, systemic amyloidosis, multiple sclerosis, uncontrolled hypertension, ...).
- •Recent administration of Metoclopramide, Droperidol, Clonidine, Dexmedetomidine
- •Nitrous oxide prior to procedural sedation
结局指标
主要结局
pupil dilation reflex
时间窗: up to 10 minutes
Amplitude of pupil dilation reflex (PRD, in % change in pupil diameter)
次要结局
- Level of sedation(up to 10 minutes)
- feasibility of the measurement(up to 10 minutes)
- Heteroevaluation of the patient's maximal pain(up to 10 minutes)
- Patient's minimal Ramsay score(up to 10 minutes)
- Pupil diameter variation using the Algiscan(up to 10 minutes)
- Pupil diameter using the Algiscan device(up to 10 minutes)
- Patient satisfaction(up to 10 minutes)