The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- NRS pruritus score at 24 hours after surgery
研究概览
简要总结
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
详细描述
Intrahepatic cholestasis of pregnancy (ICP) is an important obstetric complication that occurs in the middle and late stages of pregnancy, characterized mainly by pruritus and elevated serum total bile acid (TBA) levels.
Pruritus usually begins on the palms and soles of the feet and can gradually spread. It typically shows a 'lighter during the day and heavier at night' pattern, severely affecting the patient's quality of life. It can also lead to physical and psychological disorders, and even cause mental abnormalities and self-harming behaviors in patients.
Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief, rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an important role in the transmission of non-histaminergic itching. Eslicarbazepine acetate, as a highly selective NMDA receptor antagonist, may alleviate the transmission and propagation of itching. However, there are no reports on whether a single intravenous injection of esketamine can alleviate the pruritus symptoms of patients with pregnancy-induced intrahepatic cholestasis. This experiment aims to investigate the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with pregnancy-induced intrahepatic cholestasis.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
- •Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
- •Meet the diagnostic criteria of the "Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)" : fasting serum TBA≥10 μmol/L or postprandial serum TBA≥19 μmol/L.
- •Reporting pruritus NRS ≥ 4 points twice within one week.
- •Planned to undergo cesarean section under intraspinal anesthesia.
- •ASA classification: I - III grade.
排除标准
- •Those who are known to be allergic to the drug components or have an allergic constitution.
- •Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history.
- •Those with severe organic diseases and liver diseases.
- •Those with malignant tumors.
- •Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc.
- •Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.
- •ASA classification as grade IV.
- •Those with poor compliance and unable to complete the trial according to the research protocol.
- •Those who have participated in other drug clinical trials within the past 4 weeks.
- •Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.
研究组 & 干预措施
Placebo group of parturients with ICP and pruritus received normal saline
The equal volume of normal saline was injected intravenously after fetal delivery during the operation
干预措施: Normal Saline (0.9% NaCl) (Drug)
Group of parturients with ICP and pruritus received esketamine 0.3mg/kg
Esketamine 0.3mg/kg was injected intravenously after fetal delivery during the operation
干预措施: Esketamine 0.3mg/kg (Drug)
结局指标
主要结局
NRS pruritus score at 24 hours after surgery
时间窗: 24 hours after the surgery
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
- 5-D itch scale at 72 hours after surgery(72 hours after surgery)
- Intraoperative average blood oxygen saturation（%）(Perioperative period)
- Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)(Perioperative period)
- NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery(6 hours、12 hours、48 hours、72 hours and the seventh day after surgery)
- The incidence of pruritus on the 24 hours after surgery(24 hours after surgery)
- Total bile acid at 24 hours after surgery(24 hours after surgery)
- Pain Score (NRS)(6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery)
- The incidence of postoperative sleep disturbance on the first、second and third postoperative nights(the first、second and third nights after surgery)
- Postoperative anxiety(72 hours after the surgery)
- Postoperative depression(72 hours after the surgery)
- Key time points of the surgery(Perioperative period)
- Intraoperative average blood pressure（mmHg）(Perioperative period)
- Intraoperative average heart rate（times per minute）(Perioperative period)
- Adverse event(Within 72 hours after the surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital