Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty

NCT07699133 | Not Yet Recruiting

• 1 other identifier: KSUEK-26
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nasal Septum Deviation; Rhinoplasty; Induced Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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).

Study Arms (1)

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)

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.

Controlled Hypotension Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Scheduled for elective rhinoplasty or septorhinoplasty under general anesthesia.
• ASA physical status I or II.
• Literate and willing to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

MeSH Terms

Interventions

Hypotension, Controlled; Standard of Care

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Cengizhan Yavuz

CONTACT

+905434843329; cengizhanyavuz@windowslive.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cengizhan Yavuz, MD, Assistant Professor, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available beginning 6 months and ending 36 months following the publication of the primary research article.
• 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.