跳至主要内容
临床试验/NCT02818621
NCT02818621Unknown不适用

Does Administration of Dexmedetomidine Guided by Entropy/SPI Reduce the Requirement of Propofol and Remifentanil as Well as Increase the Quality of Recovery Profile?

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014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
入组人数
64
试验地点
1
主要终点
The difference of the requirements of propofol and remifentanil between each groups

研究概览

简要总结

Dexmedetomidine, a selective alpha2-adrenergic agonist is known to reduce propofol and opioid requirements due to its sedative and analgesic properties. However, until now, there has been studies based on indirect measures such as hemodynamics. Entropy shows to quantify the level of consciousness by EEG and Surgical pleth index(SPI) allows to predict the effect of pain stimuli and analgesic therapy by the index of the nociception-anti-nociception balance. The investigators analyzed quantitatively the requirements of propofol and remifentanil under continuous infusion of dexmedetomidine when using entropy and SPI.

详细描述

Dexmedetomidine, a selective alpha2-adrenergic agonist is known to reduce propofol and opioid requirements due to its sedative and analgesic properties. However, until now, there has been studies based on indirect measures such as hemodynamics. Entropy shows to quantify the level of consciousness by EEG and Surgical pleth index(SPI) allows to predict the effect of pain stimuli and analgesic therapy by the index of the nociception-anti-nociception balance. The investigators analyzed quantitatively the requirements of propofol and remifentanil under continuous infusion of dexmedetomidine when using entropy and SPI.

Patients (20~65 years old, ASA class 1 or 2) scheduled lumbar discectomy under general anesthesia were recruited. The patients were randomly allocated to two groups. Both groups received Target controlled infusion(TCI) of propofol and remifentanil and the dexmedetomidine was added to the Dex group and normal saline was added to the Placebo group. The Dex group received 1mcg/kg loading dose followed by 0.5mcg/kg/hr infusion of dexmedetomidine which was administered at induction of anesthesia through skin closure. The placebo group received equal amount of normal saline. During maintenance of anesthesia the effect site concentration of propofol and remifentanil was titrated to maintain Entropy(SE) 40~60 and SPI under 50. Blood pressure and heart rate also was measured. The total amount of propofol and remifentanil administered, time between eye opening and extubation was recorded. The quality of recovery was evaluated by QoR-40 survey after 24 hours postop.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.The patients (20~65 years old, ASA class 1 or 2) scheduled lumbar discectomy under general anesthesia

排除标准

  • ASA class (American Society of Anesthesiologist physical status classification) 3 or higher
  • Patients with history of allergy or side effects on propofol, remifentanil, dexmedetomidine
  • BMI (body mass index) higher than 35
  • Patients taking monoamine oxidase inhibitor or adrenergic blocking agent
  • Pregnancy, Emergency operation
  • Patients with liver disease, cognitive dysfunction or drug abuse history

研究组 & 干预措施

Group Dex

Active Comparator

The Dex group received 1mcg/kg loading dose followed by 0.5mcg/kg/hr infusion of dexmedetomidine which was administered at induction of anesthesia through skin closure.

Interventions:

◦Drug: Dexmedetomidine

干预措施: Group Dex (dexmedetomidine) (Drug)

Group Placebo

Placebo Comparator

The Placebo group received equal amount of normal saline.

Interventions:

◦Drug: Normal saline

干预措施: Group Dex (dexmedetomidine) (Drug)

结局指标

主要结局

The difference of the requirements of propofol and remifentanil between each groups

时间窗: the day of surgery

We analyzed quantitatively the requirements of propofol and remifentanil under continuous infusion of dexmedetomidine or placebo(normal saline) when using entropy and SPI.

次要结局

  • The difference of quality of recovery between each groups(24 hours after surgery)

研究者

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

Jiwon An

Associate Porfessor

Gangnam Severance Hospital

研究点 (1)

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