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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07699133
Enrollment
40
Registered
2026-07-13
Start date
2026-07-10
Completion date
2027-03-30
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induced Hypotension, Nasal Septum Deviation, Rhinoplasty

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.

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.

Interventions

PROCEDUREControlled Hypotension (Standard of Care)

Maintenance of Mean Arterial Pressure (MAP) between 50 and 65 mmHg during the surgical procedure to optimize the surgical field.

Sponsors

Kahramanmaras Sutcu Imam University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Serum Glial Fibrillary Acidic Protein (GFAP) LevelBaseline (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

MeasureTime frameDescription
Change in Montreal Cognitive Assessment (MoCA) ScoreBaseline (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).
Duration of Target HypotensionIntraoperative 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.

Contacts

CONTACTCengizhan Yavuz
cengizhanyavuz@windowslive.com+905434843329

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026