Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 主要终点
- Depression Severity
研究概览
简要总结
Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder
- •Presentation for gynecologic surgery requiring a general anesthetic
排除标准
- •Marked co-morbid cardiovascular disease
- •Marked co-morbid respiratory disease
- •History of intracranial hypertension
- •History of seizures
- •ASA Physical Status Classification IV or greater
- •History of psychosis
- •Current pregnancy
- •Contraindication to ketamine administration
研究组 & 干预措施
Control Arm
As part of the patient's anesthetic induction, they will receive propofol and fentanyl.
干预措施: Propofol (Drug)
Control Arm
As part of the patient's anesthetic induction, they will receive propofol and fentanyl.
干预措施: Fentanyl (Drug)
Ketamine Arm
As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
干预措施: Ketamine Hydrochloride (Drug)
Ketamine Arm
As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
干预措施: Propofol (Drug)
Ketamine Arm
As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Depression Severity
时间窗: 30-days post-operative
Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \>34 is severe depression.
次要结局
- Analgesia use(30-days post-operative)
- Pain Score(30-days post-op)