Administration of Acetazolamide to Prevent Remifentanil Induced Hyperalgesia: Randomize Double Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the mechanical pain threshold in an area distant to the site of the injury
研究概览
简要总结
Remifentanil is a potent opioid widely used during the administration of general anesthesia. There is a lot of evidence that suggest that the used of remifentanil is associated with the development of hyperalgesia (a reduction of nociceptive thresholds). However, the mechanism of this hyperalgesia is not fully understood.
Recently, it was demonstrated that the disruption of the Cl- homeostasis could be involved. Interestingly, this was prevented in a murine model with the administration of Acetazolamide, a carbonic anhydrase inhibitor. In our clinical trial we will try to determine if the preoperative administration of acetazolamide could prevent the hyperalgesia induced by remifentanil in patients scheduled for thyroidectomy with general anesthesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for thyroidectomy with general anesthesia in the University of Chile Clinical Hospital
排除标准
- •Patients ASA III y IV
- •Chronic pain history
- •Drug and alcohol abuse
- •Chronic use of opioid and sedatives
- •Neuropsychiatric illness
- •NSAID and other analgesics used the 48 hours previous to the surgery
- •CMI > 30
研究组 & 干预措施
Acetazolamide
250 mg VO of acetazolamide will be administered the day of the surgery 2 hours before anesthesia induction
干预措施: Acetazolamide (Drug)
Placebo
An oral tablet without active principle acetazolamide but with the same physical characteristics will be administered the day of the surgery 2 hours before anesthesia induction
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in the mechanical pain threshold in an area distant to the site of the injury
时间窗: 12-18 hours after the end of the surgery
The threshold will be determine using von Frey monofilaments before the surgery and will be compared 12-18 hours after the end of the surgery
次要结局
- Change in the mechanical pain threshold in an area distant to the site of the injury(2 hours after the end of the surgery)
- Postoperative pain(The first postoperative day)
- Morphine consumption(The first postoperative day)
研究者
Rodrigo Gutiérrez
MD
University of Chile