Processed EEG Monitoring During Controlled Hypotension in Patients Undergoing Rhinoplasty
25 de junio de 2026 actualizado por: Elif KARAKAYA, Gazi University
Observational Evaluation of the Relationship Between Intraoperative Processed EEG Monitoring,Surgical Bleeding and Recovery Quality in Patients Undergoing Rhinoplasty Under Controlled Hypotension
This prospective observational study evaluates intraoperative processed electroencephalography parameters in adult patients undergoing elective rhinoplasty under total intravenous anesthesia with controlled hypotension.
The study focuses on qCON and qNOX values during anesthesia, their relationship with early postoperative recovery, and their association with intraoperative surgical bleeding and surgical field quality.
Descripción general del estudio
Estado
Terminado
Descripción detallada
Controlled hypotension is commonly used during rhinoplasty to improve surgical field visibility and reduce bleeding. However, the adequacy and safety of controlled hypotension should not be evaluated only by hemodynamic variables. Processed EEG monitoring may provide additional information about hypnotic depth and the probability of response to nociceptive stimulation.
In this prospective observational study, adult patients undergoing elective rhinoplasty under general anesthesia were monitored with standard ASA monitoring and processed EEG monitoring. Total intravenous anesthesia was maintained with propofol and remifentanil. Esmolol infusion was used as part of the controlled hypotension strategy. Intraoperative qCON and qNOX values, hemodynamic parameters, surgical bleeding scores, anesthetic drug consumption, extubation time, time to reach Aldrete score ≥9, and early postoperative cognitive recovery were recorded.
The primary objective is to evaluate the intraoperative course of qCON and qNOX values during controlled hypotension. Secondary objectives are to assess the relationship of processed EEG parameters with recovery quality, early postoperative cognitive status, anesthetic drug consumption, and surgical field bleeding.
Tipo de estudio
De observación
Inscripción (Actual)
64
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.
Ubicaciones de estudio
-
-
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Ankara, Turquía (Türkiye)
- Gazi University
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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
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult patients scheduled for elective rhinoplasty under general anesthesia at Gazi University Faculty of Medicine were included in this prospective observational study.
All patients underwent total intravenous anesthesia with esmolol-supported controlled hypotension and intraoperative processed EEG monitoring.
Hemodynamic parameters, qCON and qNOX values, surgical bleeding scores, anesthetic drug consumption, and early postoperative recovery outcomes were recorded.
Descripción
Inclusion Criteria:
- Patients aged 18 years or older
- Patients scheduled for elective rhinoplasty
- Patients classified as ASA physical status I-II
- Patients planned to undergo general anesthesia with total intravenous anesthesia
- Patients in whom frontal processed EEG electrodes can be applied
- Patients who provide written informed consent
Exclusion Criteria:
- Emergency surgery
- Severe neurological disease
- Scalp lesion or marked dermatitis preventing processed EEG electrode placement
- Communication or hearing impairment preventing postoperative assessment
- Marked hemodynamic instability
- Multiple trauma or need for postoperative intensive care unit admission
- Pregnancy
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative qCON and qNOX values during controlled hypotension
Periodo de tiempo: From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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qCON and qNOX values obtained by processed EEG monitoring will be recorded at predefined intraoperative time points.
qCON will be used as an index of hypnotic depth, and qNOX will be used as an index of the probability of response to nociceptive stimulation.
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From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart rate during controlled hypotension
Periodo de tiempo: From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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Heart rate will be recorded at predefined intraoperative time points to evaluate hemodynamic stability.
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From baseline before anesthesia induction until the end of surgery, up to approximately 150 minutes intraoperatively.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Surgical field bleeding score
Periodo de tiempo: Intraoperatively, from surgical incision until the end of surgery.
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Surgical field bleeding will be evaluated using the Boezaart surgical field bleeding score at predefined intraoperative time points.
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Intraoperatively, from surgical incision until the end of surgery.
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Extubation time
Periodo de tiempo: At the end of surgery
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Time from discontinuation of anesthetic agents to extubation will be recorded in minutes
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At the end of surgery
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Time to reach Aldrete score ≥9
Periodo de tiempo: Early postoperative recovery period, immediately after extubation.
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The time required to reach an Aldrete recovery score of 9 or higher will be recorded in minutes
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Early postoperative recovery period, immediately after extubation.
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Early postoperative delirium assessed by the Nursing Delirium Screening Scale
Periodo de tiempo: At admission to the post-anesthesia care unit
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Patients were assessed for early postoperative delirium in the post-anesthesia care unit using the Nursing Delirium Screening Scale (Nu-DESC).
The Nu-DESC ranges from 0 to 10, with higher scores indicating more severe delirium symptoms.
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At admission to the post-anesthesia care unit
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Total anesthetic drug consumption
Periodo de tiempo: From anesthesia induction until the end of surgery
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Total intraoperative consumption of propofol, remifentanil, and esmolol will be recorded
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From anesthesia induction until the end of surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Nurdan Bedirli, MD, Gazi University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Laferriere-Langlois P, Morisson L, Jeffries S, Duclos C, Espitalier F, Richebe P. Depth of Anesthesia and Nociception Monitoring: Current State and Vision For 2050. Anesth Analg. 2024 Feb 1;138(2):295-307. doi: 10.1213/ANE.0000000000006860. Epub 2024 Jan 12.
- Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Aceto P, Audisio R, Cherubini A, Cunningham C, Dabrowski W, Forookhi A, Gitti N, Immonen K, Kehlet H, Koch S, Kotfis K, Latronico N, MacLullich AMJ, Mevorach L, Mueller A, Neuner B, Piva S, Radtke F, Blaser AR, Renzi S, Romagnoli S, Schubert M, Slooter AJC, Tommasino C, Vasiljewa L, Weiss B, Yuerek F, Spies CD. Update of the European Society of Anaesthesiology and Intensive Care Medicine evidence-based and consensus-based guideline on postoperative delirium in adult patients. Eur J Anaesthesiol. 2024 Feb 1;41(2):81-108. doi: 10.1097/EJA.0000000000001876. Epub 2023 Aug 30.
- Kol IO, Kaygusuz K, Yildirim A, Dogan M, Gursoy S, Yucel E, Mimaroglu C. Controlled hypotension with desflurane combined with esmolol or dexmedetomidine during tympanoplasty in adults: A double-blind, randomized, controlled trial. Curr Ther Res Clin Exp. 2009 Jun;70(3):197-208. doi: 10.1016/j.curtheres.2009.06.001.
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)
1 de noviembre de 2025
Finalización primaria (Actual)
25 de febrero de 2026
Finalización del estudio (Actual)
25 de febrero de 2026
Fechas de registro del estudio
Enviado por primera vez
20 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
26 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de febrero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 172
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared due to institutional and ethical restrictions and to protect participant confidentiality.
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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