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Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty

7. juli 2026 opdateret af: Cengizhan Yavuz, Kahramanmaras Sutcu Imam University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Serum Glial Fibrillary Acidic Protein (GFAP) Level
Tidsramme: 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).
Baseline (T0: Post-induction) and 24 hours postoperatively (T1).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Montreal Cognitive Assessment (MoCA) Score
Tidsramme: 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).
Baseline (Preoperative ward visit) and 24 hours postoperatively.
Duration of Target Hypotension
Tidsramme: 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.
Intraoperative period (from surgical incision to end of surgery, approximately 1-3 hours).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kahramanmaras Sutcu Imam University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juli 2026

Primær færdiggørelse (Anslået)

28. februar 2027

Studieafslutning (Anslået)

30. marts 2027

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KSUEK-26

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Data will become available beginning 6 months and ending 36 months following the publication of the primary research article.

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Rhinoplastik

Kliniske forsøg med Controlled Hypotension (Standard of Care)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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