Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- (PTSD)
研究概览
简要总结
Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.
详细描述
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (K group and D group). Using computer generated randomization table; each group consists of 26 patients: K group (n=26): Patient will receive with 0.5 mg/kg/h ketamine infusion. D group (n=26): Patient will receive 0.1 ug/kg/h dexmedetomidine infusion.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-60 years old.Body mass index of less than or equal 35.American Society of I and II.Duration of surgery not more than 3 hours.
排除标准
- •Known hypersensitivity to dexmedetomidine or ketamine. Hemorrhagic shock decompensation.History of alcohol or drug abuse.History of neurologic or psychiatric diseases Advanced renal ,liver or cardiovascular disorders.
研究组 & 干预措施
Ketamine(K)
0.5 mg/kg/h ketamine infusion
干预措施: ketamine (Drug)
dexmedetomidine(D)
0.1 ug/kg/h dexmedetomidine infusion
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
(PTSD)
时间窗: 6 months
To measure the change in PTSD symptom severity using the PTSD Checklist
次要结局
- VAS((24 hours, 48 hours, and 1 month))
- postoperative delirium(twice daily for 3 days)
研究者
Marwa Mohamed Medhat
assistant professor of anesthesia and surgical intensive care (Principal Investigator)
Zagazig University