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临床试验/NCT03525912
NCT03525912已完成不适用

Neuropsychiatric and Cardiovascular Side Effects in Ketamine Analgesic Infusions: a Prospective Study

Universidad de Antioquia1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2017年7月1日最近更新:
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
入组人数
101
试验地点
1
主要终点
Delirium

研究概览

简要总结

Evaluation of neuropsychiatric and cardiovascular side effects of low dose ketamine analgesic infusion for postoperative pain

详细描述

Postoperative pain is a world wide problem related with surgery. Multimodal analgesia may include ketamine, aimed to decrease opioid adverse effects in postoperative analgesia for major surgery, and risk of chronic postsurgical pain. Ketamine has shown efficacy as adjuvant in multimodal analgesia, however, neuropsychiatric and cardiovascular effects of ketamine at low doses in continue postoperative infusion are less known. This type of adverse effects may compromise appropriated recovery.

Objective

to determine frequency of delirium, agitation, sedation, hallucinations, bad dreams and cardiovascular changes associated with ketamine analgesic infusion treatment for postoperative pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • patient scheduled for abdominal, thoracic or orthopedic surgery

排除标准

  • cognitive disfunction psychiatric illness cardiovascular disease

研究组 & 干预措施

Ketamine infusion

Experimental

postoperative pain in adult population after abdominal, thoracic and orthopedic surgery that received adjuvant analgesia with ketamine 0.1mg/kg/h during 24 to 48 hours in postoperative period.

干预措施: Ketamine (Drug)

结局指标

主要结局

Delirium

时间窗: 2 days

Presence or absence of delirium at 24 and 48 hours postoperatively over the past 2 days of exposure to ketamine infusion, using the Confusion Assessment Method (CAM), a clinical based assessment tool for identifying delirium. Consist of 4 criteria ( timing of symptoms, attention, thinking, consciousness). Considered to be positive for delirium if both features 1 and 2 are present, with at least one of features 3 or 4.

次要结局

  • Sedation(24 and 48 hours postoperatively)
  • Agitation(24 and 48 hours postoperatively)

研究者

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

Adriana Margarita Cadavid

Professor

Universidad de Antioquia

研究点 (1)

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