Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorKırıkkale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
18 Participants
are grouped into 1 trial groupGroup A: Patients undergoing bimaxillary orthognathic surgery
Trial outcomes
Primary outcomes
1
Number of Participants With Trigeminocardiac Reflex (TCR)
The occurrence of trigeminocardiac reflex (TCR) during surgery will be assessed, and the number of participants who experience TCR will be reported
Time frame
During surgerySecondary outcomes
1
Systolic Blood Pressure
Systolic blood pressure will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
Time frame
During surgery2
Diastolic Blood Pressure
Diastolic blood pressure will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
Time frame
During surgery3
Heart Rate
Heart rate will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
Time frame
During surgery4
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO₂) will be recorded at 5-minute intervals during surgery and evaluated according to the different stages of bimaxillary orthognathic surgery.
Time frame
During surgerySponsors and contacts
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Source ClinicalTrials.gov