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NCT Number: NCT07726251

Hemodynamic Changes and Trigeminocardiac Reflex During 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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kırıkkale Univesity Faculty of Dentistry

Kirikkale, Kırıkkale, 71450, Turkey (Türkiye)

Location status: Recruiting

Location contact

Elif Assistant Professor, DDS

CONTACT

[email protected]

+90 318 224 4927 ext. 71

Elif Çoban, DDS

PRINCIPAL_INVESTIGATOR

Mert Research Assistant, DDS

CONTACT

[email protected]

+90 318 2244927 ext. 7130

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elif Assistant Professor, DDS

CONTACT

[email protected]

+90 318 224 4927 ext. 71

Mert Research Asistant, DDS

CONTACT

[email protected]

+90 318 2244927 ext. 7130

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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