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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled Hypotension Cohort | Patients undergoing elective rhinoplasty receiving standard intraoperative controlled hypotension (Target MAP: 50-65 mmHg) maintained with sevoflurane and remifentanil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled Hypotension (Standard of Care) | Procedure | Maintenance of Mean Arterial Pressure (MAP) between 50 and 65 mmHg during the surgical procedure to optimize the surgical field. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Glial Fibrillary Acidic Protein (GFAP) Level | GFAP is a biomarker of astrocyte stress and blood-brain barrier permeability. Measured via ELISA (pg/mL). | Baseline (T0: Post-induction) and 24 hours postoperatively (T1). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montreal Cognitive Assessment (MoCA) Score | The MoCA is a 30-point screening tool for detecting cognitive dysfunction. Higher scores indicate better cognitive function (Range: 0-30). | Baseline (Preoperative ward visit) and 24 hours postoperatively. |
| Duration of Target Hypotension |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult patients, aged 18 to 50 years, who are scheduled to undergo elective primary rhinoplasty or septorhinoplasty under general anesthesia at the Department of Otorhinolaryngology and Plastic Surgery, Kahramanmaras Sutcu Imam University Hospital. Patients will be selected from those with an American Society of Anesthesiologists (ASA) physical status of I or II, ensuring a healthy cohort without severe systemic diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cengizhan Yavuz | Contact | +905434843329 | cengizhanyavuz@windowslive.com |
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De-identified individual participant data (IPD) that underlie the results reported in the final publication will be shared upon reasonable request. Data will only be shared for academic, non-commercial purposes to ensure compliance with personal data protection regulations.
Data will become available beginning 6 months and ending 36 months following the publication of the primary research article.
Data will be shared with researchers who provide a methodologically sound research proposal. Requests should be directed to the corresponding author via email. Requestors will be required to sign a data access agreement.
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| ID | Term |
|---|---|
| D007023 | Hypotension, Controlled |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Total time (in minutes) the patient's Mean Arterial Pressure (MAP) is maintained within the target range of 50-65 mmHg. |
| Intraoperative period (from surgical incision to end of surgery, approximately 1-3 hours). |
| D017530 | Health Care Quality, Access, and Evaluation |