Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty

Evaluation of the Effect of Controlled Hypotension During Elective Rhinoplasty on Serum Glial Fibrillary Acidic Protein (GFAP) and Cognitive Functions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rhinoplasty; Nasal Septum Deviation; Induced Hypotension
• Intervention / Treatment: Procedure: Controlled Hypotension (Standard of Care)

Detailed Description

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 (Estimated): 40

Contacts and Locations

• Study Contact: Name: Cengizhan Yavuz; Phone Number: +905434843329; Email: cengizhanyavuz@windowslive.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controlled Hypotension Cohort; Patients undergoing elective rhinoplasty receiving standard intraoperative controlled hypotension (Target MAP: 50-65 mmHg) maintained with sevoflurane and remifentanil.	Procedure: Controlled Hypotension (Standard of Care); Maintenance of Mean Arterial Pressure (MAP) between 50 and 65 mmHg during the surgical procedure to optimize the surgical field.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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	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).

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Anesthesia and Analgesia; Standard of Care; Hypotension, Controlled
• Other Study ID Numbers: KSUEK-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available beginning 6 months and ending 36 months following the publication of the primary research article.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No