Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHitit University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lower MAP Target Strategy (50-60 mmHg)
Other interventionControlled 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)
Other interventionControlled 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Lower MAP Target (50-60 mmHg)Experimental treatment 1 intervention
Group B: Higher MAP Target (60-70 mmHg)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Peripapillary Vessel Density at 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.
Time frame
Preoperative baseline (1-7 days before surgery) to 24-72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov