Infrared Pupillometry - Effects of Different Types of General Anesthesia on Postoperative Pupillary Reactivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- The AUC of Pupillary Light Reflex
研究概览
简要总结
Objective: To compare the effects of volatile and intravenous anesthetics on pupillary function after general anesthesia using a portable infrared pupillometer.
Design: A monocentric, prospective, double blinded randomized study.
Patients: Patients who require elective Ear, Nose and Throat (ENT) surgery under general anesthesia.
Interventions: Patients undergoing elective ENT surgery will be assigned to intravenous versus inhalative anesthesia and pupillometric parameters monitored postoperative, using an infrared pupillometer.
Outcomes measures: Reported pupillometric parameters after intravenous and inhalative anesthesia.
The purpose of this study is to compare general anesthesia techniques (volatile, intravenous) on postoperative changes in pupillary reactivity by using infrared pupillometry.
详细描述
Introduction: With the increased focus on early discharge after surgery and anesthesia, it is important to identify objective criteria that can be used to assess home-readiness after ambulatory surgery. Premature discharge may lead to a higher rate of patients suffering complications and to an increased readmission rate. Time-consuming objective evaluations of postoperative vigilance status like EEG registrations are not practicable in routine postoperative clinical practice.
In this study an approach to a more quantitative judgment of postoperative vigilance and consciousness is made by recording pupillometric measurements using a portable infrared pupillometer. The findings of this study may provide new important insights to the meaning of pupillary responses for postoperative vigilance measurement.
Aim: With regard to the lack of knowledge about mechanisms that enable the central nervous system to restore consciousness after the deep functional disorder of the anesthetized state, this study aims to compare general anesthesia techniques (volatile, intravenous) on postoperative changes in pupillary reactivity by using infrared pupillometry.
The primary aim of this study is to investigate changes in pupillary reactivity (pupillary light reflex (PLR, %) in the early postoperative phase (2 hours) after common used types of general anesthesia techniques (inhaled - sevoflurane versus intravenous - propofol).
Secondary aim is to examine whether decreased postoperative PLR predicts a decline in neuropsychological testing (alertness).
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, Investigator)
盲法说明
double blinded study design (participants, evaluator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 and ≤99 years
- •Patients undergoing elective ENT surgery under general anesthesia
排除标准
- •Patients aged < 18 and >99 years
- •consumption of antidepressants, tranquilizer, psychotropic medications
- •history of mental illness, neurosurgery, neurological or psychiatric disease
- •ophthalmologic disease
- •preexisting cognitive impairment
- •Patients with drug dependence, alcoholism
- •the patients' inability to follow procedures
- •implanted electronic medical devices
结局指标
主要结局
The AUC of Pupillary Light Reflex
时间窗: baseline and within the first 2 postoperative hours
The AUC of PLR (percentage change, %) measured every 15 minutes during the first 2 postoperative hours.
次要结局
- Alertness assessed with the Digit Symbol Substitution Test(baseline and within the first 2 postoperative hours)
- Alertness assessed with the Visual Intrinsic Alertness Test Score(baseline and within the first 2 postoperative hours)
- Alertness assessed with the Trail making Test Score(baseline and within the first 2 postoperative hours)
研究者
Marita Windpassinger M.D.
Principal Investigator
Medical University of Vienna