Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry
研究概览
简要总结
The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.
After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to pediatric burns care unit
- •Burnt skin area 5-40%
- •Scheduled for a dressing change under ketamine sedation
排除标准
- •Neurologic or ophthalmic disease
研究组 & 干预措施
Ketamine sedation
Procedure scheduled under ketamine sedation. Baseline pupillary diameter measurement in alert subjects. Injection of a bolus of 1 mg/kg of ketamine. Every minute, tetanic stimulations of incremental intensities (10-20-30-40-60 milliamps), during 5 seconds.
Pupillary diameter measurement before and after each stimulation. End of study period, beginning of procedure.
干预措施: ketamine (Drug)
Ketamine sedation
Procedure scheduled under ketamine sedation. Baseline pupillary diameter measurement in alert subjects. Injection of a bolus of 1 mg/kg of ketamine. Every minute, tetanic stimulations of incremental intensities (10-20-30-40-60 milliamps), during 5 seconds.
Pupillary diameter measurement before and after each stimulation. End of study period, beginning of procedure.
干预措施: Tetanic stimulations of incremental intensities (Procedure)
结局指标
主要结局
Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry
时间窗: 30 seconds after each stimulation (6 stimulations per patient)
Non-invasive measurement of pupillary diameter using an infrared camera, for each of the 6 stimulations per patient
次要结局
- Heart rate variation(30 seconds after each stimulation)
研究者
Pr Isabelle CONSTANT
Professor
Hôpital Armand Trousseau