Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pupillary diameter
研究概览
简要总结
In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.
详细描述
The aim of the study was to investigate a possible correlation between the intensity of a nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized with propofol and remifentanil target-controlled infusion.
Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and propofol target concentration adjusted to maintain bispectral index between 45 and 55.
Study period: 6 tetanic stimulations of incremental intensities were applied to the patients: 10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was recorded.
Then, propofol and remifentanil infusions were discontinued, and patients were extubated.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation
- •written informed consent
排除标准
- •ophthalmic disease
- •neurologic disease
- •preoperative chronic pain or pain medication
- •medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)
研究组 & 干预措施
pupillometry
General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph
干预措施: general anesthesia for scheduled gynecological surgery (Procedure)
pupillometry
General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph
干预措施: Propofol (Drug)
pupillometry
General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph
干预措施: Remifentanil, Ultiva® (Drug)
pupillometry
General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph
干预措施: tetanic stimulations (Procedure)
pupillometry
General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph
干预措施: VideoAlgesiGraph (Device)
结局指标
主要结局
Pupillary diameter
时间窗: 1 minute after tetanic stimulation
as measured by VideoAlgesiGraph, in mm
次要结局
- Heart rate(1 minute after tetanic stimulation)
研究者
Pr Isabelle CONSTANT
Professor
Hôpital Armand Trousseau