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临床试验/NCT02058511
NCT02058511终止不适用

Intraoperative Use of Infrared Pupillometry During General Anesthesia to Predict Pain and Quality of Regional Anesthesia After Surgery

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
1
主要终点
Pain in Recovery Room

研究概览

简要总结

The study comprises of a series of pupillary measurements using infrared pupillometry in patients undergoing arthroscopic knee surgery of any type.

Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. This may help to predict the amount of discomfort a patient will be experiencing after emergence from general anesthesia.

In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after indiction of anesthesia, as well as during recovery. These spontaneously occuring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed.

The aim of the study is

  1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks will block the PRD. This would allow assessment of block success in the anesthetized patient.
  2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.

详细描述

The planned study is a prospective cohort study.

Patients undergoing arthroscopic knee surgery of any type (debridements, repair of anterior (ACL) or posterior cruciform ligaments (PCL), meniscectomies, medial (MCL) or lateral collateral ligament (LCL) repair, as well as microfracture surgery will be enrolled.

During anesthesia, infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. The PRD is measurable under general anesthesia in spite of the fact that the patient does not "feel" or experience the painful stimulus.

The aim of the study is

  1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks (performed before the start of anesthesia) will block the PRD evoked by a painful stimulus such electrical stimulation before procedure start. This would allow assessment of block success in the anesthetized patient.
  2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years undergoing arthroscopic knee surgery of any type

排除标准

  • Blindness
  • Anisocoria
  • History of opioid abuse
  • Chronic pain patients
  • Gastric Reflux Disease (due to the use of laryngeal masks in the study)
  • Non english speaking patients
  • Cognitive impairment

研究组 & 干预措施

Intervention Group

Experimental

all enrolled patients undergo the same protocol/ treatment:

Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs

干预措施: Anesthesia Premedication, Induction and Maintenance (Drug)

Intervention Group

Experimental

all enrolled patients undergo the same protocol/ treatment:

Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs

干预措施: Pupillometry after administration of anesthetic drugs (Procedure)

结局指标

主要结局

Pain in Recovery Room

时间窗: at arrival in recovery room

Pain as assessed by visual analogue score at arrival of the patient in the recovery room Scale goes from 0-10, with 10 indicating the worst pain possible

次要结局

  • Number of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditions(measurements were taken at two time points during surgery. Each measurement took 30 seconds)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Behrends

Associate Clinical Professor

University of California, San Francisco

研究点 (1)

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