Orthognathic SurgeryNCT07726251
Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery
An observational study of Orthognathic Surgery and Trigeminocardiac Reflex, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Orthognathic Surgery, Trigeminocardiac Reflex, Hemodynamic
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2026to 20 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kırıkkale Univesity Faculty of Dentistry
Kirikkale, Kırıkkale, 71450
Elif Assistant Professor, DDS, +90 318 224 4927 ext. 71, elifcoban@kku.edu.tr
Mert Research Assistant, DDS, +90 318 2244927 ext. 7130, bilgim979899@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthognathic Surgery, Trigeminocardiac Reflex, Hemodynamic
- Keywords
- Trigeminocardiac Reflex, Bimaxillary Orthognathic Surgery, Hemodynamic Changes, Intraoperative Complications, Autonomic Nervous System
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing bimaxillary orthognathic surgery | Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During surgery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Jun 2026
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Çoban, Kırıkkale University
- Investigators
- Elif Çoban, DDS, Principal investigator, Kırıkkale University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726251
- Sponsor's protocol ID
- Decision No: 2026.04.66
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Evaluation of Hemodynamic Parameters Using Routine Intraoperative Monitoring Data in Patients Undergoing Bimaxillary Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07726251
- Acronym / sponsor ID
- Decision No: 2026.04.66
- Conditions
- Orthognathic Surgery, Trigeminocardiac Reflex, Hemodynamic
- Keywords
- Trigeminocardiac Reflex, Bimaxillary Orthognathic Surgery, Hemodynamic Changes, Intraoperative Complications, Autonomic Nervous System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing bimaxillary orthognathic surgery | – | –Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Trigeminocardiac Reflex (TCR)
Time frame: During surgery
The occurrence of trigeminocardiac reflex (TCR) during surgery will be assessed, and the number of participants who experience TCR will be reported
4 secondary outcomes
Systolic Blood Pressure
Time frame: During surgery
Diastolic Blood Pressure
Time frame: During surgery
Heart Rate
Time frame: During surgery
Peripheral Oxygen Saturation
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elif Çoban, DDS principal investigator
Kırıkkale University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery and Trigeminocardiac Reflex, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Assistant Professor, DDS (+90 318 224 4927 ext. 71, elifcoban@kku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Trigeminocardiac Reflex (TCR) (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.