Effects of Esketamine on Acute Abdominal Pain After TACE in Patients With Hepatocellular Carcinoma:a Prospective Study TACE(Transcatheter Arterial Chemoembolization)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Intensity at 4hours after the beginning of TACE operation
研究概览
简要总结
Pain is the main complication after TACE(Transcatheter Arterial Chemoembolization) for hepatocellular carcinoma, and its pathogenesis is not clear.The pain may be related to partial liver tissue swelling after blocking the tumor blood supply artery embolization agent, transient hepatic swelling causing tension or strain on the liver capsule, and chemical irritation by the anticancer drug-Lipiodol mixture,the inadvertent embolization of normal organs and individual sensitivity to pain. Ketamine produces anesthetic and analgesic effects mainly by inhibiting NMDA receptor(N-methyl-D-aspartic acid receptor), and previous studies have shown that low concentrations of ketamine have obvious analgesic effects. Not only that, ketamine also produces analgesic effects by inhibiting opioid receptors via G-protein coupling. In addition, ketamine can bind to monoaminergic receptors in the central and peripheral nervous system, showing an anticholinergic effect and producing an antispasmodic effect. Ketamine also inhibits inflammatory pain by reducing nitric oxide production by inhibiting nitric oxide synthase. Esketamine is about three to four times more potent than ketamine. Therefore,esketamine requires a lower dose, about half the dose of ketamine, to produce anesthetic and analgesic effects, with fewer side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •Participate in this study and sign informed consent
- •Voluntarily receive preoperative intravenous analgesia
- •Patients receiving TACE treatment
- •HCC (hepatocellular carcinoma)patients with primary liver cancer BCLC(Barcelona Clinic Liver Cancer) stage A-C, liver function A-B
排除标准
- •Patients who were unable to cooperate or refused to participate in the trial
- •Pregnant women
- •Patients with or having a history of serious mental disorders
- •Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic / diastolic blood pressure more than 180/100mg)
- •Patients with unstable angina pectoris or myocardial infarction within 6 months or congestive heart failure
- •Patients with intracranial hypertension or glaucoma
- •Patients with hyperthyroidism without treatment or insufficient treatment
- •Patients with severe respiratory dysfunction
- •Allergy or existing contraindication to chemotherapeutic drugs, opioids or ketamine drugs
研究组 & 干预措施
Esketamine-PCIA(patient controlled intravenous analgesia)
PCIA formula#100ml analgesic solution was prepared by adding 2.5 mg/kg Esketamine and 8mg ondansetron into normal saline.
干预措施: Esketamine (Drug)
Sufentanil-PCIA(patient controlled intravenous analgesia)
PCIA formula#100ml analgesic solution was prepared by adding 2 μ g/kg sufentanil and 8mg ondansetron into normal saline.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Pain Intensity at 4hours after the beginning of TACE operation
时间窗: From 0 to 4hours after the beginning of TACE
Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome)
Pain Intensity at 12hours after the beginning of TACE operation
时间窗: From 8hours to 12hours after the beginning of TACE operation
Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome)
Pain Intensity at 8hours after the beginning of TACE operation
时间窗: From 4hours to 8hours after the beginning of TACE operation
Pain intensity is assessed by numerical rating scale pain scores(0-10,0 represents painless,10 represents intolerable pain;higher scores mean a worse outcome)
次要结局
- Pain Intensity at 30hours after the beginning of TACE operation(From 24hours to 30hours after the beginning of TACE operation)
- Pain Intensity at 36hours after the beginning of TACE operation(From 30hours to 36hours after the beginning of TACE operation)
- Maximum Pain Intensity in the First 4hours after the beginning of TACE operation(From the beginning of TACE operation to 4hours after the beginning of TACE operation)
- Maximum Pain Intensity in the Third 4hours after the beginning of TACE operation(From 8hours to 12hours after the beginning of TACE operation)
- Pain Intensity at 18hours after the beginning of TACE operation(From 12hours to 18hours after the beginning of TACE operation)
- Maximum Pain Intensity in the Second 4hours after the beginning of TACE operation(From 4hours to 8hours after the beginning of TACE operation)
- Pain Intensity at 42hours after the beginning of TACE operation(From 36hours to 42hours after the beginning of TACE operation)
- Pain Intensity at 24hours after the beginning of TACE operation(From 18hours to 24hours after the beginning of TACE operation)
- Pain Intensity at 48hours after the beginning of TACE operation(From 42hours to 48hours after the beginning of TACE operation)
- Analgesic Consumption(From 0 to 48 hours after the beginning of TACE operation)