The Effect of Dexmedetomidine Infusion Alone Versus the Combination of Dexmedetomidine and Melatonin on Reduction of Post-operative Delirium (POD) After Open Brain Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of POD
研究概览
简要总结
The aim of this study is to illuminate the effect of combination of dexmedetomidine and oral melatonin versus the use of dexmedetomidine infusion alone on the improving of post-operative delirium (POD) on patients undergoing open brain surgeries.
详细描述
Study Population: Patients undergoing open brain surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:
- Group A will receive Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr) in addition to oral placebo tablets.
- Group B will receive Dexmedetomidine IV Infusion at rate of (0.5 μg/kg/hr) in addition to oral Melatonin (3 mg/tablet).
- Study Procedures:
A. Preoperative settings:
All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30 - 60 years
- •Sex: Both sexes
- •Patients with open space occupying lesions or hematoma.
排除标准
- •Refusal of the patient to give written informed consent.
- •History of allergy to the medications used in the study.
- •Psychiatric disorder.
- •Any form of drug addiction.
- •Patients receiving any anti-psychotic medications.
- •History of previous brain insult (Ischemic or haemorrhagic infarctions).
- •Pre-operative dementia.
- •History of malignant hyperthermia
- •Patient's suffering from bradycardia
- •Patient's suffering from hypotension
研究组 & 干预措施
Control Group
Dexmedetomidine alone
干预措施: Dexmedetomidine (DEX) (Drug)
Combination Group
Combination of Dexmedetomidine & Melatonin
干预措施: Dexmedetomidine (DEX) (Drug)
Combination Group
Combination of Dexmedetomidine & Melatonin
干预措施: Melatonin (Drug)
结局指标
主要结局
The incidence of POD
时间窗: Perioperatively
Through calculation of CAM-ICU Score \& RASS score of patient
次要结局
未报告次要终点