Comparison of Remifentanil-induced Postoperative Hyperalgesia After Gynecological Laparoscopic Surgery Between Patients From the Plain Area and the Plateau Area
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
研究概览
简要总结
Purpose:
- To compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas
- To compare the peri-operative analgesic requirements of patients in plain and plateau areas
详细描述
Our research group has been committed to the research of remifentanil-induced hyperalgesia for a long time. In the previous study, it was found that intraoperative infusion of remifentanil (0.3ug/kg•min) >1h can lead to remifentanil-induced hyperalgesia and the incidence rate is relative high in the plain area. Due to the long-term low pressure and hypoxia of people living in plateau areas, a series of changes will occur in the respiratory and circulatory systems, and their anesthesia management needs to be adjusted accordingly. However, there is no relevant research on whether or not hyperalgesia occurs in people in plateau areas (altitude level >3000 meters). Therefore, this study hopes to compare the incidence and degree of remifentanil-induced hyperalgesia after gynecological laparoscopic surgery in plain areas and plateau areas.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is scheduled to undergo gynecological laparoscopic 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.
- •Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.
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 any drugs used during general anesthesia.
- •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/m2).
研究组 & 干预措施
Remifentanil-analgesia in plateau area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
干预措施: plateau areas (Other)
Sufentanil-analgesia in plain area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.
干预措施: Sufentanil injection (Drug)
Sufentanil-analgesia in plain area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.
干预措施: plain areas (Other)
Remifentanil-analgesia in plain area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.
干预措施: Remifentanil Hydrochloride (Drug)
Remifentanil-analgesia in plain area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.
干预措施: plain areas (Other)
Sufentanil-analgesia in plateau area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
干预措施: Sufentanil injection (Drug)
Sufentanil-analgesia in plateau area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
干预措施: plateau areas (Other)
Remifentanil-analgesia in plateau area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
干预措施: Remifentanil Hydrochloride (Drug)
结局指标
主要结局
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
时间窗: 48 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 after surgery
次要结局
- Pain Score (NRS)(48 hours after surgery)
- Normalized Area of Hyperalgesia Around the Incision(48 hours after surgery)
- Mechanical hyperalgesia threshold around the incision(48 hours after surgery)
- Time of First Postoperative Analgesic Requirement(1 hour after surgery)
- Total Dose of First Postoperative Analgesic Requirement(1 hour after surgery)
- Cumulative Hydromorphone Consumption(48 hours after surgery)
- Occurrence of Side Effects(48 hours after surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital