Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery

July 24, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Kırıkkale
      • Kirikkale, Kırıkkale, Turkey (Türkiye), 71450
        • Recruiting
        • Kırıkkale Univesity Faculty of Dentistry
        • Contact:
        • Principal Investigator:
          • Elif Çoban, DDS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing bimaxillary orthognathic surgery
Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

Investigators

  • Principal Investigator: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2026

Primary Completion (Estimated)

June 20, 2027

Study Completion (Estimated)

July 20, 2027

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 24, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Decision No: 2026.04.66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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