Effect of Esketamine on Reducing Postoperative Anxiety and Depression in Adolescent Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Anxiety and depression scale scores 1 month after surgery
研究概览
简要总结
This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 8-17 years old are selected as subjects. Esketamine is used as intervention before surgery, vital signs data, serum IL-6, CRP and other inflammatory indicators are collected during surgery, and the incidence and degree of anxiety and depression are evaluated after surgery. To determine the effect of esketamine on reducing anxiety and depression in adolescents after surgery, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after 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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8 years ≤ age ≤17 years;
- •Patients who plan to undergo elective surgery under general anesthesia, and the operation time is ≥2h;
- •ASA grade I-II
排除标准
- •Patients expected to be admitted to ICU after surgery;
- •Patients who need to return to the ward with tracheal intubation after surgery;
- •Allergic to the active ingredients or excipients of isketamine hydrochloride injection;
- •Patients with severe consciousness disorder or mental system disease (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
- •Patients with congenital heart disease and severe developmental delay;
- •Patients with one of the following contraindications to esketamine :(a) patients at risk of a significant increase in blood pressure or intracranial pressure; (b) Patients with ocular hypertension (glaucoma) or penetrating ocular trauma; (c) Patients with poorly controlled or untreated hypertension (resting systolic blood pressure greater than 180 mmHg or resting diastolic blood pressure greater than 100 mmHg); (d) Untreated or undertreated hyperthyroidism;
- •Previous history of ketamine abuse or dependence, drug or alcohol dependence for more than 6 months, previous ketamine ineffective tests or adverse reactions.
研究组 & 干预措施
Experimental group
Esketamine (0.25mg/kg)
干预措施: Esketamine (Drug)
结局指标
主要结局
Anxiety and depression scale scores 1 month after surgery
时间窗: 1 month
Anxiety and depression scale scores 1 month after surgery
次要结局
未报告次要终点