跳至主要内容
临床试验/NCT02576600
NCT02576600已完成不适用

Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption

Pr Isabelle CONSTANT1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2010年10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
已完成
发起方
入组人数
65
试验地点
1
主要终点
peroperative remifentanil consumption in µg/kg/min

研究概览

简要总结

The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective gynecological surgery
  • No ophtalmologic or neurologic disease
  • No chronic analgesic medication
  • Expected length of surgery 60 minutes minimum

排除标准

  • ophtalmologic or neurologic disease
  • chronic analgesic medication

研究组 & 干预措施

PUPILLO

Experimental

Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI

干预措施: Propofol (Drug)

PUPILLO

Experimental

Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI

干预措施: Videopupillometer Algiscan (Device)

PUPILLO

Experimental

Videopupillometer Algiscan peroperative remifentanil target concentration adapted every five minutes to pupillary diameter in patients under propofol and remifentanil TCI

干预措施: Remifentanil (Drug)

STANDARD

Sham Comparator

peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI

干预措施: Standard practice (Other)

STANDARD

Sham Comparator

peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI

干预措施: Propofol (Drug)

STANDARD

Sham Comparator

peroperative remifentanil target concentration as standard practice in patients under propofol and remifentanil TCI

干预措施: Remifentanil (Drug)

结局指标

主要结局

peroperative remifentanil consumption in µg/kg/min

时间窗: duration of surgery

次要结局

  • peroperative propofol consumption in mg/kg/h(duration of surgery)
  • post-operative morphine requirements in mg/kg(24 hours)

研究者

发起方
Pr Isabelle CONSTANT
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pr Isabelle CONSTANT

Professor Isabelle Constant

Hôpital Armand Trousseau

研究点 (1)

Loading locations...

相似试验

Pupillometry Guided Remifentanil Administration and... | 临床试验