Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery
24 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
18
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Elif Assistant Professor, DDS
- Numéro de téléphone: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Mert Research Asistant, DDS
- Numéro de téléphone: 7130 +90 318 2244927
- E-mail: bilgim979899@gmail.com
Lieux d'étude
-
-
Kırıkkale
-
Kirikkale, Kırıkkale, Turquie (Türkiye), 71450
- Recrutement
- Kırıkkale Univesity Faculty of Dentistry
-
Contact:
- Elif Assistant Professor, DDS
- Numéro de téléphone: 71 +90 318 224 4927
- E-mail: elifcoban@kku.edu.tr
-
Chercheur principal:
- Elif Çoban, DDS
-
Contact:
- Mert Research Assistant, DDS
- Numéro de téléphone: 7130 +90 318 2244927
- E-mail: bilgim979899@gmail.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Patients undergoing bimaxillary orthognathic surgery
Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Trigeminocardiac Reflex (TCR)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Systolic Blood Pressure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 juin 2026
Achèvement primaire (Estimé)
20 juin 2027
Achèvement de l'étude (Estimé)
20 juillet 2027
Dates d'inscription aux études
Première soumission
21 juillet 2026
Première soumission répondant aux critères de contrôle qualité
21 juillet 2026
Première publication (Réel)
24 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Decision No: 2026.04.66
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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