Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Postoperative Hyperalgesia Induced by Remifentanil in Patients Undergoing Lower Abdomimal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
研究概览
简要总结
Purpose:
To explore and compare antihyperalgesic effects of butorphanol, flurbiprofen axetil, and a combination of both received before anesthesia induction.
To evaluate and examine the incidence of adverse effects with the purpose of selecting the optimum dose.
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详细描述
There are a dramatically increasing number of evidences that administration of the potent, ultra-short-acting opioid remifentanil seems to cause opioid-induced hyperalgesia (OIH) more frequently and predictably compared with the others, likely due to its rapid onset and offset. Therefore, prophylaxis of remifentanil induced hyperalgesia is indispensable to postoperative comfort and satisfaction.
There is no denying the fact that OIH is related to central glutaminergic system and N-methyl-d-aspartate (NMDA) receptor-activation induced central sensitization. Prostaglandins can promote glutamate release from both astrocytes and spinal cord dorsal horns with subsequent activation of the NMDA receptors, and flurbiprofen axetil, as non-steroidal anti-inflammatory drugs (NSAIDs), not only functionally antagonizes the NMDA receptor activation via inhibition of prostaglandins, but also is a targeted drug which gathers at the site of inflammation, thus greatly enhances the analgesic effect. While butorphanol has both spinal analgesic and sedative functions because of predominantly central κ-receptor agonist activation, other advantages of butorphanol include few side effects, very low addiction potential, and low toxicity on account of a partial agonist-antagonist activity to μ-receptor. Moreover, antihyperalgesic activity of κ opioids at the site of inflammation has been reported in various acute pain models. The following study is carried out to evaluate whether butorphanol combined with flurbiprofen axetil can be safely and effectively applied to preventing postoperative hyperalgesia induced by remifentanil in patients undergoing lower abdominal surgery.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is scheduled to undergo lower abdominal surgery under a short general anesthesia of less than 2 hours
- •Subject's American Society of Anesthesiologists physical status is I-II.
- •The subject's parent/legally authorized guardian has given written informed consent to participate.
排除标准
- •Subject has a diagnosis of renal or liver failure.
- •Subject has a diagnosis of Insulin dependent diabetes.
- •Subject is allergy and contraindication to butorphanol or NSAIDs.
- •Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- •Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- •Subject is pregnant or breast-feeding.
- •Subject is obese (body mass index >30kg/m^2).
研究组 & 干预措施
Normal Saline
Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Normal Saline (Drug)
Normal Saline
Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Remifentanil (Drug)
Butorphanol
Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Butorphanol (Drug)
Butorphanol
Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Remifentanil (Drug)
Flurbiprofen axetilⅠ
Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Flurbiprofen axetil (Drug)
Flurbiprofen axetilⅠ
Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Remifentanil (Drug)
Flurbiprofen axetilⅡ
Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil
干预措施: Flurbiprofen axetil (Drug)
Flurbiprofen axetilⅡ
Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil
干预措施: Remifentanil (Drug)
Butorphanol-Flurbiprofen axetil
A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Butorphanol (Drug)
Butorphanol-Flurbiprofen axetil
A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Flurbiprofen axetil (Drug)
Butorphanol-Flurbiprofen axetil
A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
干预措施: Remifentanil (Drug)
Sufentanil
Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
干预措施: Normal Saline (Drug)
Sufentanil
Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
干预措施: Sufentanil (Drug)
结局指标
主要结局
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
时间窗: 24 hours after surgery
The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively
次要结局
- Normalized Area of Hyperalgesia Around the Incision(24 hours after surgery)
- Occurrence of Side Effects(24 hours)
- Cumulative Sufentanyl Consumption(24 hours)
- Total Dose of First Postoperative Analgesic Requirement(1 hour after surgery)
- Pain Score (NRS)(3h, 6h, 12h, and 24h after surgery)
- Time of First Postoperative Analgesic Requirement(1 hour post surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital