Evaluation of the Effect of Controlled Hypotension During Elective Rhinoplasty on Serum Glial Fibrillary Acidic Protein (GFAP) and Cognitive Functions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change in Serum Glial Fibrillary Acidic Protein (GFAP) Level
研究概览
简要总结
This prospective observational study aims to evaluate the neurological safety of controlled hypotension (Mean Arterial Pressure 50-65 mmHg) during elective rhinoplasty. The investigators will assess whether this standard intraoperative hypotensive strategy causes cellular stress by measuring serum Glial Fibrillary Acidic Protein (GFAP) levels and early postoperative cognitive changes using the Montreal Cognitive Assessment (MoCA) test.
详细描述
Controlled hypotension is frequently utilized in rhinoplasty to minimize bleeding and improve the surgical field. However, the potential cellular stress on the brain due to reduced cerebral perfusion is not fully understood. This study will enroll 40 ASA I-II patients undergoing elective rhinoplasty under general anesthesia with sevoflurane. Blood samples will be drawn at baseline (after anesthesia induction) and 24 hours postoperatively to measure serum GFAP levels via ELISA. Cognitive functions will be evaluated simultaneously using the MoCA test. The primary objective is to determine the change in GFAP concentrations, and the secondary objective is to evaluate its correlation with early postoperative cognitive scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective rhinoplasty or septorhinoplasty under general anesthesia.
- •ASA physical status I or II.
- •Literate and willing to provide written informed consent.
排除标准
- •History of neurological (e.g., cerebrovascular event, epilepsy) or psychiatric diseases.
- •Total septal reconstruction requiring costal (rib) cartilage grafts.
- •Expected surgical duration exceeding 3 hours.
- •Preoperative severe cognitive impairment.
- •Pregnancy or lactation.
研究组 & 干预措施
Controlled Hypotension Cohort
Patients undergoing elective rhinoplasty receiving standard intraoperative controlled hypotension (Target MAP: 50-65 mmHg) maintained with sevoflurane and remifentanil.
干预措施: Controlled Hypotension (Standard of Care) (Procedure)
结局指标
主要结局
Change in Serum Glial Fibrillary Acidic Protein (GFAP) Level
时间窗: Baseline (T0: Post-induction) and 24 hours postoperatively (T1).
GFAP is a biomarker of astrocyte stress and blood-brain barrier permeability. Measured via ELISA (pg/mL).
次要结局
- Change in Montreal Cognitive Assessment (MoCA) Score(Baseline (Preoperative ward visit) and 24 hours postoperatively.)
- Duration of Target Hypotension(Intraoperative period (from surgical incision to end of surgery, approximately 1-3 hours).)
研究者
Cengizhan Yavuz
Cengizhan Yavuz, MD, Assistant Professor, Department of Anesthesiology and Reanimation
Kahramanmaras Sutcu Imam University