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Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery

Observational Evaluation of Hemodynamic Parameters Using Routine Intraoperative Monitoring Data in Patients Undergoing Bimaxillary Orthognathic Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07726251
Enrollment
18
Registered
2026-07-24
Start date
2026-06-20
Completion date
2027-07-20
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic, Orthognathic Surgery, Trigeminocardiac Reflex

Keywords

Trigeminocardiac Reflex, Bimaxillary Orthognathic Surgery, Hemodynamic Changes, Intraoperative Complications, Autonomic Nervous System

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Kırıkkale University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Trigeminocardiac Reflex (TCR)During surgeryThe occurrence of trigeminocardiac reflex (TCR) during surgery will be assessed, and the number of participants who experience TCR will be reported

Secondary

MeasureTime frameDescription
Systolic Blood PressureDuring surgerySystolic blood pressure will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
Diastolic Blood PressureDuring surgeryDiastolic blood pressure will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
Heart RateDuring surgeryHeart rate will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
Peripheral Oxygen SaturationDuring surgeryPeripheral oxygen saturation (SpO₂) will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.

Countries

Turkey (Türkiye)

Contacts

CONTACTElif Assistant Professor, DDS
elifcoban@kku.edu.tr+90 318 224 4927
CONTACTMert Research Asistant, DDS
bilgim979899@gmail.com+90 318 2244927
PRINCIPAL_INVESTIGATORElif Çoban, DDS

Kırıkkale University Faculty of Dentistry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026