The Effects of Dexmedetomidine on Postoperative Cognitive Function and Neuron-Specific Enolase Levels in Open Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Serum neuron-specific enolase levels
研究概览
简要总结
To assess the impact of Dexmedetomidine on postoperative cognitive function and serum Neuron Specific Enolase levels as an indicator of neuronal injury in patients undergoing open heart surgery
详细描述
This randomized controlled study was conducted to evaluate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing elective open-heart surgery. Patients were randomly assigned into two groups: a dexmedetomidine group receiving intravenous dexmedetomidine infusion during surgery and a control group receiving normal saline infusion as placebo in addition to standard anesthesia.
Postoperative cognitive function was assessed using the Mini-Mental State Examination (MMSE). Serum neuron-specific enolase (NSE) levels were measured as a biomarker of neuronal injury. Intraoperative depth of anesthesia was monitored using the bispectral index (BIS). The aim of the study was to investigate whether dexmedetomidine administration could reduce postoperative cognitive dysfunction and neuronal injury in patients undergoing cardiac surgery.
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, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and outcome assessors were blinded to group allocation. Dexmedetomidine and placebo solutions were prepared in identical syringes by an independent anesthesiologist not involved in patient management or data collection.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes undergoing elective open-heart surgery
排除标准
- •Patients with a history of neurological disorders, severe renal or liver dysfunction, or contraindications to Dexmedetomidine as in patients with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia, or hypomagnesemia, and in patients receiving other drugs known to prolong the QT interval.
- •Patients with cognitive impairment, mental and psychological illness and chronic alcoholics, drug addicts, abuse of psychotropic substances, illiterate education
研究组 & 干预措施
Group B (Dexmedetomidine)
Patients receive intravenous dexmedetomidine infusion during open-heart surgery in addition to standard anesthesia.
干预措施: Dexmedetomidine (Drug)
Group A (control)
Patients receive intravenous normal saline infusion during surgery as placebo control in addition to standard anesthesia.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Serum neuron-specific enolase levels
时间窗: Preoperative baseline and 12 hours after surgery
Serum neuron-specific enolase levels will be measured as a biomarker of neuronal injury.
Postoperative cognitive function
时间窗: Preoperative baseline, and at 1 day, 3 days, and 7 days after surgery
Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE).
次要结局
- Postoperative cognitive function(Preoperative baseline, and at 1 day, 3 days, and 7 days after surgery)
- Serum neuron-specific enolase levels(Preoperative baseline and 12 hours after surgery)
研究者
Salaheldin Ahmed Abdelziz
specialist
Sohag University