Effect of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Severe Depression: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Chinese PLA General Hospital
- 入组人数
- 242
- 主要终点
- Perioperative anxiety and depreession
概览
简要总结
This project employs a prospective, randomized, controlled, blinded, dual-center study design to investigate the effects of intraoperative esketamine on perioperative anxiety and depression symptoms in patients with severe depression undergoing breast cancer surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Scheduled to undergo elective breast cancer resection surgery.
- •American Society of Anesthesiologists (ASA) physical status classification of I-III.
- •Clearly understand and voluntarily agree to participate in the study, and sign the informed consent form.
- •Female patients with severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥15)
- •Anticipated anesthesia duration greater than 90 minutes.
排除标准
- •Patients with significant preoperative abnormalities in cardiac, pulmonary, hepatic, or renal function, or coagulation disorders .
- •Patients taking antipsychotics, antidepressants, or glucocorticoids, or with a history of alcohol abuse or illicit drug use .
- •Patients with an MMSE score \<18, dementia, intellectual disability, or those unable to communicate (e.g., coma, severe dementia, hearing or language impairment) .
- •Patients with a history of psychiatric or neurological disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) .
- •Patients with poorly controlled or untreated hypertension (≥180/110 mmHg) .
- •Patients with elevated intracranial or intraocular pressure.
- •Patients with untreated or inadequately treated hyperthyroidism .
- •Patients with a known allergy to the drugs involved in this study .
- •Patients unable to complete the assessment scales required by this study.
- •Patients who are currently participating in other clinical trials
研究组 & 干预措施
Esketamine group
Patients who undergo general anesthesia using esketamine.
干预措施: Esketamine 0.3mg/kg (Drug)
Control group
Patients who undergo general anesthesia without esketamine
干预措施: normal saline (Drug)
结局指标
主要结局
Perioperative anxiety and depreession
时间窗: Preoperative day 1, postoperative day 3 ,day 7 and day 30
The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale . Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.
次要结局
- Postoperative Sleep Quality(Preoperative day 1, postoperative day 3 ,day 7 and day 30)
- Delirium(Within 7 days after surgery)
- PONV(Within 2 days after extubation)
- Postoperative Recovery Quality(Postoperative day 3 ,day 7 and day 30)
- Postoperative Pain(Postoperative day 3 ,day 7 and day 30)
- Postoperative Quality of Life(postoperative day 3 ,day 7 and day 30)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital