Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty

N/ANot Yet RecruitingNCT07699133

Kahramanmaras Sutcu Imam University40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Nasal Septum Deviation Rhinoplasty Induced Hypotension

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Scheduled for elective rhinoplasty or septorhinoplasty under general anesthesia. * ASA physical status I or II. * Literate and willing to provide written informed consent. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline (T0: Post-induction) and 24 hours postoperatively (T1).

Secondary Outcomes

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).

Time frame: Baseline (Preoperative ward visit) and 24 hours postoperatively.

Duration of Target Hypotension

Total time (in minutes) the patient's Mean Arterial Pressure (MAP) is maintained within the target range of 50-65 mmHg.

Time frame: Intraoperative period (from surgical incision to end of surgery, approximately 1-3 hours).

Central Contacts

Cengizhan Yavuz

CONTACT

+905434843329 cengizhanyavuz@windowslive.com

Data from ClinicalTrials.gov

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