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NCT Number: NCT07699133

Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty

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.

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Key information

Conditions

Nasal Septum Deviation Induced Hypotension Rhinoplasty

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Serum Glial Fibrillary Acidic Protein (GFAP) Level

    Time frame: 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).

Secondary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) Score

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

    The MoCA is a 30-point screening tool for detecting cognitive dysfunction. Higher scores indicate better cognitive function (Range: 0-30).

  2. Duration of Target Hypotension

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cengizhan Yavuz

CONTACT

[email protected]

+905434843329

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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