Effect of Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Perioperative anxiety and depreession
研究概览
简要总结
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Patients 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.
- •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 (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) 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 (HADS-D) 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(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