NCT06624878招募中不适用
Intraoperative Esketamine for Prevention of Depressive Symptoms After Cytoreductive Surgery in Ovarian Cancer: a Controlled, Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 568
- 试验地点
- 1
- 主要终点
- the incidence of postoperative depressive symptoms after cytoreductive surgery in ovarian cancer
研究概览
简要总结
The goal of this clinical trial is to learn if intraoperative administration of esketamine would prevent or mitigate postoperative depressive symptoms after cytoreductive surgery in ovarian cancer. The main questions it aims to answer are:
- Whether a single low dose of esketamine administered would reduce the postoperative depressive symptoms three days after cytoreductive surgery in ovarian cancer?
- Whether a single low dose of esketamine administered would relief the postoperative sleep disturbance, postoperative recovery? Researchers will compare the esketamine to a placebo (normal saline) to see if the esketamine works to reduce the postoperative depressive symptoms.
Participants will:
- Receive either 0.2 mg/kg esketamine or placebo infused intravenously after induction of general anesthesia.
- The preoperative Patient Health Questionnaire 9 (PHQ-9) scale was used to verify the symptoms suggestive of depression.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •undergoing cytoreductive surgery for ovarian cancer under general anesthesia
- •ASA physical status I-III
- •Ages 18-80 years
排除标准
- •Patients taking anti-psychotic medications
- •Contraindications to esketamine
- •Language barrier
- •Inability to provide consent
研究组 & 干预措施
the esketamine group
Experimental
干预措施: esketamine (Drug)
the placebo group
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
the incidence of postoperative depressive symptoms after cytoreductive surgery in ovarian cancer
时间窗: on postoperative day 3
The postoperative depressive symptoms are assessed using the preoperative Patient Health Questionnaire 9 (PHQ-9) scale. The range of this scale is 0-27, and a standard threshold score of 10 or higher indicates symptoms of depression.
次要结局
- the incidence of depressive symptoms in ovarian cancer(Baseline (before surgery), on postoperative day 30)
- the incidence of sleep disturbance in ovarian cancer(Baseline (before surgery), on postoperative day 3 and on postoperative day 30)
- the incidence of anxiety in ovarian cancer(Baseline (before surgery))
- the postoperative recovery of ovarian cancer(Baseline (before surgery), on postoperative day 3)
- postoperative pain score at rest and coughing pain(at 1, 24, 48, 72 hours after surgery)
- the lengh of postoperative ICU admission(through study completion, an average of 1-5 days)
- the time to initiation of postoperative chemotherapy(through study completion, an average of 5-20 days)
- the postoperative complications of ovarian cancer(within 30 days after surgery)
- the time to walk after surgery(through study completion, an average of 2-5 days)
- the time to return of bowel function(through study completion, an average of 5-10 days)
- the time to readiness for discharge(through study completion, an average of 7-15 days)
- morphine requirements after surgery(at 48 hours after surgery)
- the residual disease after cytoreductive surgery(on postoperative day 1)
- the incidence of nausea and vomiting(during 72 hours after surgery)
- the incidence of postoperative hypotension(during 72 hours after surgery)
- the incidence of pruritus(during 72 hours after surgery)
- the incidence of drowsiness(during 72 hours after surgery)
- the incidence of respiratory depression(during 72 hours after surgery)
- the incidence of nystagmus(during 72 hours after surgery)
- the incidence of diplopia(during 72 hours after surgery)
- the incidence of hypertonia(during 72 hours after surgery)
- the incidence of daymare(during 72 hours after surgery)
- the incedence of neuropsychiatric symptoms(during 72 hours after surgery)
- the incidence of dissociative states(during 72 hours after surgery)
研究者
Gu Bin
Clinical Professor
Zhejiang Cancer Hospital
研究点 (1)
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