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Clinical Trials in Turkey / NCT07832305
Recruiting Not applicable

Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty

NCT07832305 · tracked via the Priya Life Science Turkey tracker
Sponsor
Hitit University
Phase
Not applicable
Started
2026-07-08
Last updated
2026-09-21

Condition(s) studied

Controlled Hypotension for Nasal Surgeries

Investigational drug(s) / intervention(s)

Lower MAP Target Strategy (50-60 mmHg)Higher MAP Target Strategy (60-70 mmHg)

Lower MAP Target Strategy (50-60 mmHg): Controlled hypotension will be maintained with a target mean arterial pressure (MAP) of 50-60 mmHg during general anesthesia. MAP will be continuously monitored, and anesthetic management will be titrated as clinically appropriate to maintain the assigned target range.

Higher MAP Target Strategy (60-70 mmHg): Controlled hypotension will be maintained with a target mean arterial pressure (MAP) of 60-70 mmHg during general anesthesia. MAP will be continuously monitored, and anesthetic management will be titrated as clinically appropriate to maintain the assigned target range.

Study summary

This randomized controlled trial aims to evaluate the effects of two different mean arterial pressure (MAP) targets during controlled hypotension on ocular perfusion and optic nerve head microvasculature in patients undergoing elective rhinoplasty or septorhinoplasty.

A total of 60 patients will be randomized in a 1:1 ratio to a target MAP of either 50-60 mmHg or 60-70 mmHg during general anesthesia. Intraocular pressure (IOP) will be measured at predefined perioperative time points, and estimated ocular perfusion pressure (OPP) will be calculated using simultaneous MAP and IOP measurements. Optical coherence tomography angiography (OCTA) will be performed preoperatively and postoperatively to assess changes in peripapillary, optic nerve head, and macular microvascular parameters.

The primary objective is to compare changes in peripapillary vessel density between the two MAP target groups. Secondary objectives include evaluating changes in optic nerve head microvasculature, intraoperative OPP and IOP, and the relationships between the depth and duration of hypotension and OCTA-derived microvascular changes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18-50 years * Scheduled for elective rhinoplasty or septorhinoplasty * American Society of Anesthesiologists (ASA) physical status I-II * Willing and able to provide written informed consent Exclusion Criteria: * History of glaucoma, retinal disease, optic neuropathy, or other significant ophthalmologic disease * Previous ocular surgery * High myopia * Uncontrolled hypertension, diabetes mellitus, or other serious systemic disease * ASA physical status III or higher * Development of severe intraoperative hemodynamic instability * Massive intraoperative bleeding * Inadequate OCTA image quality for analysis * Pregnancy * Refusal to participate or withdrawal of consent

Primary outcome measure(s)

  • Change in Peripapillary Vessel Density at 24-72 Hours After Surgery — Preoperative baseline (1-7 days before surgery) to 24-72 hours after surgery
    Change in peripapillary vessel density measured by optical coherence tomography angiography (OCTA) from the preoperative baseline to 24-72 hours after surgery. Vessel density will be quantified using the same OCTA device and scanning protocol for all assessments. The primary comparison will be the difference in change from baseline between the two randomized MAP target groups.

Trial sites (1)

FacilityCityRegionStatus
Hitit university Çorum Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07832305 on ClinicalTrials.gov ↗ ← All trials in Turkey