- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sibel ÖNEN ÖZDEMİR
- Número de telefone: +905442892194
- E-mail: sibelonen89@gmail.com
Locais de estudo
-
-
-
Çorum, Turquia (Türkiye)
- Recrutamento
- Hitit university
-
Contato:
- Ozgur Yagan, Professor
- Número de telefone: +90 364 222 11 00
- E-mail: tipfak@hitit.edu.tr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Peripapillary Vessel Density at 24-72 Hours After Surgery
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-136
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .