An observational study in Orthognathic Surgery, Trigeminocardiac Reflex and Hemodynamic, sponsored by Kırıkkale University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Kırıkkale University · Observational
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.
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.
92 studies on the registry are indexed under Intraoperative Complications; 19 are open to participants now.
This study's planned enrollment of 18 is below the median of 200 across 39 observational studies indexed under Intraoperative Complications.
Browse Intraoperative Complications studies →Kırıkkale University is the lead sponsor of 114 studies on the registry; 24 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring.
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 surgery
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 surgery
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 surgery
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 surgery
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 surgery
Plan to share: No — 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.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.
Of 23 observational studies under Intraoperative Complications, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 17. This study's planned 12 months is close to that.
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Intraoperative Complications →