[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656908":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":25,"studyPopulation":13,"armGroups":26,"interventions":39,"overallOfficials":13,"centralContacts":48,"locations":54,"responsibleParty":71,"collaborators":13,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":13,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":13,"enrollmentInfo":84,"targetDuration":13,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":57,"whyStopped":13,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Hitit University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Preoperative baseline (1-7 days before surgery) to 24-72 hours after surgery",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to one of two parallel groups according to the target mean arterial pressure (MAP) during controlled hypotension: 50-60 mmHg or 60-70 mmHg. Each participant will remain in the assigned MAP target group throughout the intraoperative study period.","PREVENTION",{"masking":20,"maskingDescription":21,"whoMasked":22},"DOUBLE","Participants and the ophthalmologist performing the postoperative OCTA assessments will be blinded to group allocation. The anesthesiologist responsible for maintaining the assigned intraoperative MAP target and the surgeon will not be blinded.",[23,24],"PARTICIPANT","OUTCOMES_ASSESSOR","Controlled hypotension is commonly used during rhinoplasty to reduce intraoperative bleeding and improve surgical field visibility. However, reductions in mean arterial pressure (MAP) may also decrease ocular perfusion pressure (OPP), particularly when accompanied by changes in intraocular pressure (IOP). Although perioperative ischemic optic neuropathy is rare, hypotension and other factors that reduce tissue perfusion have been reported as potential contributors to perioperative visual complications. The effects of different controlled hypotension targets on ocular perfusion and optic nerve head microvasculature during rhinoplasty remain insufficiently characterized.\n\nThis prospective randomized controlled trial will include 60 patients aged 18-50 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective rhinoplasty or septorhinoplasty under general anesthesia. Participants will be randomized in a 1:1 ratio using computer-generated block randomization to one of two intraoperative controlled hypotension strategies: a target MAP of 50-60 mmHg or a target MAP of 60-70 mmHg. Participants and the ophthalmologist performing the postoperative OCTA assessment will be blinded to group allocation, whereas the attending anesthesiologist and surgeon will not be blinded.\n\nAll patients will receive standardized general anesthesia. MAP and other standard monitoring parameters will be continuously monitored. IOP will be measured noninvasively in the same eye using tonometry at predefined perioperative time points: before induction of anesthesia, after endotracheal intubation, after achieving the target MAP, 15 minutes after establishment of controlled hypotension, every 30 minutes thereafter during maintained hypotension, at the end of surgery, and during the early post-extubation period. MAP will be recorded simultaneously with each IOP measurement, and estimated OPP will be calculated as MAP minus IOP.\n\nOptical coherence tomography angiography (OCTA) will be performed using the same device before surgery and during postoperative follow-up. Preoperative OCTA will be obtained 1-7 days before surgery, and postoperative assessments will be performed within 24-72 hours, at 1 week, and at 1 month. OCTA-derived parameters will include peripapillary vessel density, optic nerve head vessel density, and superficial and deep macular vascular density.\n\nThe primary outcome is the change in peripapillary vessel density from the preoperative measurement to the early postoperative assessment. Secondary outcomes include changes in optic nerve head and macular microvascular parameters, minimum intraoperative estimated OPP, maximum change in IOP, and the relationships between the depth and duration of controlled hypotension and postoperative OCTA-derived microvascular changes.\n\nThe study is designed to determine whether different MAP targets used during controlled hypotension are associated with different patterns of ocular perfusion and subclinical optic nerve head microvascular change. The study is not designed to determine the incidence of perioperative ischemic optic neuropathy or other rare postoperative visual complications.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Lower MAP Target (50-60 mmHg)","EXPERIMENTAL","Participants assigned to this group will undergo controlled hypotension during general anesthesia with a target mean arterial pressure (MAP) of 50-60 mmHg. Hemodynamic parameters will be continuously monitored, and the anesthetic regimen will be titrated to maintain MAP within the assigned target range while ensuring clinical safety.",[32],"Other: Lower MAP Target Strategy (50-60 mmHg)",{"label":34,"type":35,"description":36,"interventionNames":37},"Higher MAP Target (60-70 mmHg)","ACTIVE_COMPARATOR","Participants assigned to this group will undergo controlled hypotension during general anesthesia with a target mean arterial pressure (MAP) of 60-70 mmHg. Hemodynamic parameters will be continuously monitored, and the anesthetic regimen will be titrated to maintain MAP within the assigned target range while ensuring clinical safety.",[38],"Other: Higher MAP Target Strategy (60-70 mmHg)",[40,44],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":13},"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.",[28],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":13},"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.",[34],[49],{"name":50,"role":51,"phone":52,"phoneExt":13,"email":53},"Sibel ÖNEN ÖZDEMİR","CONTACT","+905442892194","sibelonen89@gmail.com",[55],{"facility":56,"status":57,"city":58,"state":13,"zip":13,"country":59,"countryCode":13,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Hitit university","RECRUITING","Çorum","Turkey (Türkiye)",{"type":61,"coordinates":62},"Point",[63,64],34.95333,40.54889,{"lat":64,"lon":63},[67],{"name":68,"role":51,"phone":69,"phoneExt":13,"email":70},"Ozgur Yagan, Professor","+90 364 222 11 00","tipfak@hitit.edu.tr",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Sibel Onen Ozdemir","medical doctor","100656908","effects-of-different-map-targets-on-ocular-perfusion-and-optic-nerve-microvasculature-during-rhinoplasty-100656908",false,"NCT07832305","Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty","Effects of Different Mean Arterial Pressure Targets on Ocular Perfusion and OCTA-Derived Optic Nerve Head Microvasculature During Controlled Hypotension in Rhinoplasty: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-50 years\n* Scheduled for elective rhinoplasty or septorhinoplasty\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* History of glaucoma, retinal disease, optic neuropathy, or other significant ophthalmologic disease\n* Previous ocular surgery\n* High myopia\n* Uncontrolled hypertension, diabetes mellitus, or other serious systemic disease\n* ASA physical status III or higher\n* Development of severe intraoperative hemodynamic instability\n* Massive intraoperative bleeding\n* Inadequate OCTA image quality for analysis\n* Pregnancy\n* Refusal to participate or withdrawal of consent","ALL","18 Years",{"count":85,"type":86},60,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.\n\nA 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.\n\nThe 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.",[92],"Controlled Hypotension for Nasal Surgeries",[94,95,96,97,98],"Controlled Hypotension","Mean Arterial Pressure","Ischemic Optic Neuropathy","Optic Nerve Perfusion","Intraocular Pressure","2026-09-16",{"date":101,"type":102},"2026-09-21","ACTUAL",{"date":104,"type":102},"2026-07-08",{"date":106,"type":86},"2026-12-15",{"name":5,"class":6},1]