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

13 ottobre 2026 aggiornato da: Sibel Onen Ozdemir, Hitit University

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

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

This 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.

All 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.

Optical 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.

The 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.

The 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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Lower MAP Target (50-60 mmHg)

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.

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.

Comparatore attivo: Higher MAP Target (60-70 mmHg)

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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Peripapillary Vessel Density at 24-72 Hours After Surgery
Lasso di tempo: 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.

Preoperative baseline (1-7 days before surgery) to 24-72 hours after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 settembre 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

15 dicembre 2026

Date di iscrizione allo studio

Primo inviato

16 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 settembre 2026

Primo Inserito (Effettivo)

21 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2026-136

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

De-identified individual participant data that underlie the results reported in the published article may be made available upon reasonable request to the corresponding author. Data will be shared for scientifically sound research purposes, subject to approval by the study investigators and in accordance with applicable ethical and institutional requirements. No directly identifiable participant information will be shared.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .