Influence of Oral Probiotics on Anxiety and Depression in Adolescents After Non-cardiac and Non-gastrointestinal Surgeries: A Prospective, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
This study intends to conduct a prospective, double-blind, randomized, controlled trial. Adolescents aged 12-17 years old and American Society of Anesthesiologists (ASA) physical status I and II are selected as subjects. Oral probiotics is used as intervention before surgery, vital signs data, serum IL-1, IL-6, BDNF,5-HT and other inflammatory indicators are collected before surgery and after non-cardiac and non-gastrointestinal surgeries, and the incidence and degree of anxiety and depression are evaluated after non-cardiac and non-gastrointestinal surgeries. To determine the effect of esketamine on reducing anxiety and depression in adolescents after non-cardiac and non-gastrointestinal surgeries, and to provide an effective clinical basis for accelerating the rehabilitation of adolescents after non-cardiac and non-gastrointestinal surgeries.
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
- 12 Years 至 17 Years（Child）
- 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 1-2 hours;
- •ASA grade I-II
- •The body mass index falls within the normal range, which is 18.5 - 23.9 kg/m2.
排除标准
- •The patient has psychological disorders, including but not limited to bipolar affective disorder.
- •Eating disorder
- •No informed consent form
- •Due to certain serious diseases, one needs to take medication for a long period of time.
- •Personality disorder
- •Has undergone or needs to undergo gastrointestinal surgery
- •Have taken antibiotics or probiotics within the past 8 weeks
- •Pure vegetarian diet