Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Controlled Hypotension (Standard of Care).
- Who it may be relevant to
- Registry conditions: Nasal Septum Deviation, Rhinoplasty, Induced Hypotension. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Controlled Hypotension During Elective Rhinoplasty on Serum Glial Fibrillary Acidic Protein (GFAP) and Cognitive Functions
Overview
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
- 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.
Primary outcome measures
- Change in Serum Glial Fibrillary Acidic Protein (GFAP) Level [Time frame: Baseline (T0: Post-induction) and 24 hours postoperatively (T1).]
Secondary outcome measures (2)
- Change in Montreal Cognitive Assessment (MoCA) Score [Time frame: Baseline (Preoperative ward visit) and 24 hours postoperatively.]
- Duration of Target Hypotension [Time frame: Intraoperative period (from surgical incision to end of surgery, approximately 1-3 hours).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07699133 · KSUEK-26