Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorKahramanmaras Sutcu Imam University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective rhinoplasty or septorhinoplasty under general anesthesia.
ASA physical status I or II.
Literate and willing to provide written informed consent.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Controlled Hypotension (Standard of Care)
Procedure/SurgeryMaintenance of Mean Arterial Pressure (MAP) between 50 and 65 mmHg during the surgical procedure to optimize the surgical field.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Controlled Hypotension Cohort1 intervention
Trial outcomes
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).
Time frame
Baseline (T0: Post-induction) and 24 hours postoperatively (T1).Secondary outcomes
1
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).
Time frame
Baseline (Preoperative ward visit) and 24 hours postoperatively.2
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.
Time frame
Intraoperative period (from surgical incision to end of surgery, approximately 1-3 hours).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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