Comparison of Sevoflurane and Propofol Administration on Postoperative Cognitive Dysfunction in Spinal Surgery Using the Mini-Mental State Examination (MMSE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Mini-Mental State Examination (MMSE) Score
研究概览
简要总结
This study aims to compare the effects of two commonly used anesthetic agents, sevoflurane and propofol, on cognitive function after spinal surgery. Postoperative cognitive dysfunction (POCD) is a common complication following general anesthesia, particularly in complex procedures such as spinal surgery. The Mini-Mental State Examination (MMSE) will be used to assess cognitive function before surgery and at multiple time points after surgery (6 hours, 24 hours, 3 days, and 7 days).
Twenty patients undergoing elective spinal surgery will be randomly assigned to receive either sevoflurane or propofol anesthesia. Cognitive outcomes will be measured and compared between the two groups. The study will evaluate whether propofol offers better preservation of cognitive function compared to sevoflurane, which has been associated with oxidative stress and hippocampal dysfunction.
The results of this study will provide important information for anesthesiologists and surgical teams regarding the choice of anesthetic agents to minimize cognitive decline after spinal surgery, improving patient safety and postoperative recovery.
详细描述
Background:
Postoperative cognitive dysfunction (POCD) is a recognized complication following general anesthesia, particularly in major surgeries such as spinal procedures. POCD can affect memory, attention, and other cognitive domains, impacting patient recovery, quality of life, and independence after surgery. Sevoflurane, an inhalational anesthetic, has been associated with neurotoxic effects including oxidative stress and hippocampal dysfunction, which may contribute to POCD. Propofol, an intravenous anesthetic, exhibits antioxidative and anti-inflammatory properties, potentially offering neuroprotective effects.
Objective:
The primary objective of this study is to compare the incidence and severity of POCD in patients undergoing spinal surgery under sevoflurane versus propofol anesthesia, as assessed by the Mini-Mental State Examination (MMSE).
Methods:
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
- Single (Outcomes Assessor)
盲法说明
Participants are aware of the anesthesia type, but outcome assessors performing MMSE tests are blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective spinal surgery.
- •Age between 18 and 65 years.
- •ASA (American Society of Anesthesiologists) physical status I-II.
- •Able to give informed consent.
- •Willing to participate in all cognitive assessments (MMSE) before and after surgery.
排除标准
- •History of neurological disorders (e.g., dementia, stroke, epilepsy).
- •Severe psychiatric disorders.
- •Known allergy or contraindication to sevoflurane or propofol.
- •History of drug or alcohol abuse.
- •Patients undergoing emergency spinal surgery.
- •Inability to understand or complete MMSE assessment.
研究组 & 干预措施
Sevoflurane Group
Inhalational anesthesia using sevoflurane. Dose and duration will follow standard anesthetic protocols for spinal surgery. Cognitive outcomes will be measured postoperatively using MMSE.
干预措施: Sevoflurane Administration (Drug)
Propofol Group
Patients in this group will receive general anesthesia using propofol during elective spinal surgery. Postoperative cognitive function will be assessed using the Mini-Mental State Examination (MMSE) at 6 hours, 24 hours, 3 days, and 7 days after surgery.
干预措施: Propofol Administration (Drug)
结局指标
主要结局
Change in Mini-Mental State Examination (MMSE) Score
时间窗: Preoperatively (baseline), 6 hours, 24 hours, 3 days, and 7 days postoperatively
Cognitive function of participants will be assessed using the Mini-Mental State Examination (MMSE) at multiple time points postoperatively. The change from baseline MMSE scores will be compared between the sevoflurane and propofol groups to evaluate the incidence and severity of postoperative cognitive dysfunction (POCD).
次要结局
未报告次要终点
研究者
Isak Lambas
Principal Investigator - Department of Anesthesiology and Intensive Therapy, Universitas Sumatera Utara
Universitas Sumatera Utara