Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery
24 de julio de 2026 actualizado por: Elif Çoban, Kırıkkale University
Observational Evaluation of Hemodynamic Parameters Using Routine Intraoperative Monitoring Data in Patients Undergoing Bimaxillary Orthognathic Surgery
This observational study aims to evaluate hemodynamic changes occurring during bimaxillary orthognathic surgery using routinely collected intraoperative monitoring data. Heart rate, systolic and diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded during different stages of surgery as part of standard clinical care.
The study will also evaluate the occurrence of the trigeminocardiac reflex (TCR) and its association with patient characteristics and surgical stages. No additional interventions, laboratory tests, or procedures will be performed beyond routine clinical practice. The findings may contribute to the early recognition and management of intraoperative hemodynamic changes during orthognathic surgery.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
This study will use a prospective observational cohort design.
Patients undergoing bimaxillary orthognathic surgery at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kırıkkale University, will be included.
Intraoperative hemodynamic data routinely collected as part of standard clinical monitoring will be recorded and analyzed.
Hemodynamic parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and peripheral oxygen saturation, will be recorded at 5-minute intervals throughout the surgical procedure.Hemodynamic parameters will be evaluated according to the different stages of surgery.
The maxillary surgical stages will include anesthesia induction, incision, bone cutting, pterygoid intraoral incision, right and left lateral wall osteotomies, medial and lateral nasal wall osteotomies, maxillary down-fracture, maxillary mobilization, plate fixation, and suturing.
The mandibular surgical stages will include anesthesia induction, incision, lingula incision, external oblique incision, osteotomy, mandibular separation, mandibular mobilization, plate fixation, and suturing.The occurrence of trigeminocardiac reflex (TCR) will be assessed simultaneously with the hemodynamic parameters recorded at each surgical stage.
TCR will be classified as mild when heart rate and/or blood pressure decreases by 10-20% from baseline values and as severe when the decrease exceeds 20% and/or is accompanied by cardiac rhythm disturbances.
Patients with and without TCR will be compared with respect to demographic characteristics and intraoperative hemodynamic changes observed during different surgical stages.
No additional interventions, laboratory tests, or invasive procedures will be performed beyond routine clinical care.
The findings of this study are expected to improve the understanding of intraoperative hemodynamic responses and contribute to the early recognition and management of TCR during bimaxillary orthognathic surgery.
Tipo de estudio
De observación
Inscripción (Estimado)
18
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Elif Assistant Professor, DDS
- Número de teléfono: 71 +90 318 224 4927
- Correo electrónico: elifcoban@kku.edu.tr
Copia de seguridad de contactos de estudio
- Nombre: Mert Research Asistant, DDS
- Número de teléfono: 7130 +90 318 2244927
- Correo electrónico: bilgim979899@gmail.com
Ubicaciones de estudio
-
-
Kırıkkale
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Kirikkale, Kırıkkale, Turquía (Türkiye), 71450
- Reclutamiento
- Kırıkkale Univesity Faculty of Dentistry
-
Contacto:
- Elif Assistant Professor, DDS
- Número de teléfono: 71 +90 318 224 4927
- Correo electrónico: elifcoban@kku.edu.tr
-
Investigador principal:
- Elif Çoban, DDS
-
Contacto:
- Mert Research Assistant, DDS
- Número de teléfono: 7130 +90 318 2244927
- Correo electrónico: bilgim979899@gmail.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
The study population will consist of adult patients aged 18-40 years who are scheduled to undergo bimaxillary orthognathic surgery at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Kırıkkale University.
Eligible participants who provide written informed consent will be enrolled in this prospective observational cohort study.
During surgery, routinely monitored intraoperative hemodynamic parameters and the occurrence of the trigeminocardiac reflex (TCR) will be evaluated according to the different stages of the surgical procedure.
Descripción
Inclusion Criteria:
- Adults aged 18-40 years.
- Patients with an indication for bimaxillary orthognathic surgery.
- Patients with complete routine intraoperative hemodynamic monitoring data.
- Patients who provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients without an indication for bimaxillary orthognathic surgery.
- Individuals younger than 18 years or older than 40 years.
- Patients with known cardiovascular disease, including arrhythmia, heart failure, coronary artery disease, or other significant cardiovascular disorders.
- Patients with systemic diseases, including diabetes mellitus, hypertension, thyroid disorders, or other significant systemic conditions.
- Patients with diagnosed psychiatric disorders.
- Patients with incomplete or irregularly recorded intraoperative hemodynamic monitoring data.
- Individuals who refuse to participate or do not provide written informed consent.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Patients undergoing bimaxillary orthognathic surgery
Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Trigeminocardiac Reflex (TCR)
Periodo de tiempo: During surgery
|
The occurrence of trigeminocardiac reflex (TCR) during surgery will be assessed, and the number of participants who experience TCR will be reported
|
During surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Systolic Blood Pressure
Periodo de tiempo: During surgery
|
Systolic blood pressure will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
|
During surgery
|
|
Diastolic Blood Pressure
Periodo de tiempo: During surgery
|
Diastolic blood pressure will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
|
During surgery
|
|
Heart Rate
Periodo de tiempo: During surgery
|
Heart rate will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
|
During surgery
|
|
Peripheral Oxygen Saturation
Periodo de tiempo: During surgery
|
Peripheral oxygen saturation (SpO₂) will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
|
During surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de junio de 2026
Finalización primaria (Estimado)
20 de junio de 2027
Finalización del estudio (Estimado)
20 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2026
Publicado por primera vez (Actual)
24 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Decision No: 2026.04.66
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
De-identified individual participant data, including demographic characteristics, intraoperative hemodynamic parameters (systolic blood pressure, diastolic blood pressure, heart rate, and peripheral oxygen saturation), surgical stage data, and trigeminocardiac reflex (TCR) data, will be made available upon reasonable request to the corresponding author after publication of the study results.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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