The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery .
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- postoperative delirium
研究概览
简要总结
This is prospective double-blinded placebo-randomized controlled trial that aims to compare the effect of preoperative administration of oral duloxetine 60 mg on decreasing the incidence of postoperative delirium in cancer patients undergoing surgery.
详细描述
This is prospective double-blinded placebo-randomized controlled trial that aims to compare the effect of preoperative administration of oral duloxetine 60 mg on decreasing the incidence of postoperative delirium in cancer patients undergoing surgery.
The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups . Duloxetine group (Group D): patients received oral duloxetine 60 mg 2 hours just before operation. Control group (Group C): patients received an identical placebo pill 2 hours just before operation
Interventions:
The preoperative anaesthetic assessment will be carried out including patient medical history , examination including baseline heart rate and blood pressure recording and review of patients' CBC , coagulation profile and chemistry investagations. In the operating room in all patients a large bore IV access (18 gauge) will be inserted.
All patients will be connected to standard routine monitoring ( non-invasive blood pressure , electrocardiography and peripheral oxygen saturation) . patients will undergo surgery under general anasthesia [ induction with IV anaesthetics (propofol 2mg/kg ) , atracurium 0.5mg/kg and maintenance with inhalational anesthesia (sevoflurane and isoflurane ). patients will be transferred to ICU after surgery . CAM-ICU will be measured every eight hours (three times a day) until the patient wiil be discharged from the ICU. Positive CAM-ICU will be considered to be delirium.
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)
盲法说明
The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups .
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will sign an informed consent prior to inclusion in the study.
- •Adult patients with ASA class I-III, undergoing cancer surgery.
排除标准
- •Patients with pre-existing neuro- cognitive dysfunction.
- •Documented signs of dementia after psychiatric evaluations.
- •Language barriers or deafness.
- •Psychosis stroke, meningitis, or brain tumors
研究组 & 干预措施
Duloxetine group (Group D)
patients received oral duloxetine 60 mg 2 hours just before operation.
干预措施: Duloxetine 60 MG (Drug)
Control group (Group C)
patients received an identical placebo pill 2 hours just before operation.
干预措施: Duloxetine 60 MG (Drug)
结局指标
主要结局
postoperative delirium
时间窗: 48 postoperative
Patients that will recieve preoperative duloxetine will transported to ICU .CAM-ICU will be measured every eight hours (three times a day) until the patient wiil be discharged from the ICU. Positive CAM-ICU will be considered to be delirium.
次要结局
未报告次要终点
研究者
Amira Hassan Ahmed Ali
Egypt , Assiut governorate.
Assiut University