The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery: A Single-center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NRS scores for pruritus assessed in the morning and evening on postoperative day 1
研究概览
简要总结
To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery
详细描述
Cholestatic pruritus is a common and refractory symptom in patients undergoing hepatobiliary surgery, often caused by impaired bile excretion due to bile duct stones, biliary tumors, or bile duct strictures. Patients typically present with moderate to severe pruritus, initially or most severely affecting the palms and soles, which significantly impairs quality of life and is frequently accompanied by sleep disturbances, anxiety, and depression. Esketamine, as an NMDA receptor antagonist, exhibits anti-hyperalgesic effects and inhibits central sensitization. Recent studies suggest that it may also alleviate refractory pruritus. This study aims to investigate the effect of intraoperative continuous infusion of esketamine on cholestatic pruritus in patients undergoing hepatobiliary 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 (Participant, 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
- •1. Inclusion Criteria:
- •Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
- •Manifestations of cholestatic pruritus, typically with the palms and soles as the initial or most severely affected sites, which may extend to the limbs and trunk; possibly accompanied by jaundice (yellowing of the skin and sclera), dark urine (e.g., tea-colored), and clay-colored stools; often with a tendency to worsen at night.
- •Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
- •Scheduled for elective hepatobiliary surgery under general anesthesia, including but not limited to: partial hepatectomy, common bile duct exploration, choledocholithotomy, biliary-enteric anastomosis (e.g., Roux-en-Y anastomosis), pancreaticoduodenectomy (Whipple procedure), and radical resection of hilar cholangiocarcinoma.
- •American Society of Anesthesiologists (ASA) physical status classification I-III.
- •Age ≥ 18 years, body mass index (BMI) between 18 and 30 kg/m², regardless of gender.
- •Patients have fully understood the nature of the study, voluntarily agree to participate, and have signed the informed consent form.
排除标准
- •Known allergy to any component of the study drug or history of allergic constitution;
- •History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
- •History of neurological disease; history of chronic pain; substance abuse or alcoholism; long-term use of opioids; administration of opioids within 48 hours prior to surgery;
- •ASA physical status classification IV;
- •Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, renal dysfunction, or marked electrolyte abnormalities;
- •History of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
- •Respiratory insufficiency or respiratory failure;
- •Preoperative diagnosis of severe liver failure of Child-Pugh class C or presence of hepatic encephalopathy;
- •Other pruritic disorders: uremic pruritus, polycythemia vera, cutaneous T-cell lymphoma, hypereosinophilia, drug eruption and drug-induced pruritus, as well as other pruritic diseases that may be easily confused, such as atopic dermatitis, pemphigoid, scabies, delusional parasitosis, dermatitis artefacta, etc.;
- •Pregnant or breastfeeding women;
- •BMI < 18 kg/m² or BMI > 30 kg/m²;
- •Poor compliance or inability to complete the study according to the protocol;
- •Participation in another drug clinical trial within the past 4 weeks;
- •Any other condition that, in the opinion of the investigators, makes the patient unsuitable for enrollment.
研究组 & 干预措施
Patients receiving esketamine intervention
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation.
干预措施: Esketamine (Drug)
Patients receiving an equal volume of saline
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
干预措施: normal Saline (Drug)
结局指标
主要结局
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
时间窗: The morning and evening of the first day after the operation
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.
次要结局
- The NRS scores for pruritus in the morning and evening on the second and third days after the operation.(On the morning and evening of the second and third days after the operation)
- The incidence of sleep disorders on postoperative days 1-3(The first, second and third days after the surgery)
- Postoperative anxiety(1 day before surgery ,1 -3 days after surgery)
- Postoperative depression(1 day before surgery ,1 -3 days after surgery)
- Pain Score (NRS)(1-3 days after surgery)
- 5-D itch scale at 72 hours after surgery(72 hours after surgery)
- Liver function tests (LFTs)(Preoperative baseline and postoperative day one)
- Postoperative Complications(Within 72 hours postoperatively)
研究者
Guolin Wang
professor
Tianjin Medical University General Hospital