Nasal Septum DeviationNCT07699133
Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty
An observational study of Nasal Septum Deviation and Rhinoplasty, run by Kahramanmaras Sutcu Imam University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Nasal Septum Deviation, Rhinoplasty, Induced Hypotension
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2026to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study 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.
Who may be able to join
- Scheduled for elective rhinoplasty or septorhinoplasty under general anesthesia.
- ASA physical status I or II.
- Literate and willing to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasal Septum Deviation, Rhinoplasty, Induced Hypotension
- Being tested
- Controlled Hypotension (Standard of Care)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Hypotension (Standard of Care)Procedure or surgery
Maintenance of Mean Arterial Pressure (MAP) between 50 and 65 mmHg during the surgical procedure to optimize the surgical field.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Hypotension Cohort | Patients undergoing elective rhinoplasty receiving standard intraoperative controlled hypotension (Target MAP: 50-65 mmHg) maintained with sevoflurane and remifentanil. Receives: Procedure: Controlled Hypotension (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0: Post-induction) and 24 hours postoperatively (T1).
Secondary outcomes (2)
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).
Measured: Baseline (Preoperative ward visit) and 24 hours postoperatively.
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.
Measured: Intraoperative period (from surgical incision to end of surgery, approximately 1-3 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Septum DeviationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengizhan Yavuz, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699133
- Sponsor's protocol ID
- KSUEK-26
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Controlled Hypotension During Elective Rhinoplasty on Serum Glial Fibrillary Acidic Protein (GFAP) and Cognitive Functions
- ClinicalTrials.gov ID
- NCT07699133
- Acronym / sponsor ID
- KSUEK-26
- Conditions
- Nasal Septum Deviation, Rhinoplasty, Induced Hypotension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled Hypotension Cohort | – | Procedure: Controlled Hypotension (Standard of Care)Patients undergoing elective rhinoplasty receiving standard intraoperative controlled hypotension (Target MAP: 50-65 mmHg) maintained with sevoflurane and remifentanil. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (3 listed)
- Scheduled for elective rhinoplasty or septorhinoplasty under general anesthesia.
- ASA physical status I or II.
- Literate and willing to provide written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Controlled Hypotension Cohort |
Primary outcome
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).
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Septum Deviation and Rhinoplasty, run by Kahramanmaras Sutcu Imam University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cengizhan Yavuz (+905434843329, cengizhanyavuz@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Glial Fibrillary Acidic Protein (GFAP) Level (time frame: Baseline (T0: Post-induction) and 24 hours postoperatively (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.