Clinical trial Recruiting at 1 site Observational Ages 18 to 40

Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery

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

Run by Kırıkkale University · NCT07726251 · Data updated 2026-11-12

This study tests how blood pressure, heart rate, and oxygen levels change during bimaxillary orthognathic surgery and whether the trigeminocardiac reflex occurs.

Quick facts

Study typeObservational
Ages18 Years to 40 Years
SexAll
Enrollment18 (estimated)
SponsorKırıkkale University
Academic / other
Locations1 site (Kirikkale, Kırıkkale)
StatusRecruiting
StartedJune 20, 2026
Main results expectedJune 20, 2027
Study endsJuly 20, 2027
Registry record updatedJuly 28, 2026
Trial IDNCT07726251 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18-40 undergoing planned bimaxillary orthognathic surgery with complete intraoperative monitoring data and able to provide informed consent.

Probably not a fit

Patients with incomplete monitoring data or those who do not experience intraoperative hemodynamic changes will still contribute data but may not derive direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational cohort study conducted at Kırıkkale University to document intraoperative hemodynamic changes during bimaxillary orthognathic surgery using routine monitoring data. Researchers will record heart rate, systolic and diastolic blood pressure, mean arterial pressure, and oxygen saturation at 5-minute intervals across defined surgical stages. The occurrence of the trigeminocardiac reflex will be noted and categorized by severity, and its relationship to patient characteristics and surgical stage will be explored without any additional interventions beyond standard care. The goal is to understand patterns of autonomic responses during surgery to aid early recognition and management of intraoperative hemodynamic changes.

Why it matters

Potential benefit: Understanding hemodynamic patterns and TCR occurrence may improve intraoperative monitoring and patient safety during orthognathic procedures.

How similar studies have gone: Previous observational work has shown that perioperative autonomic responses can be monitored and linked to reflexes like TCR in surgical settings, though this specific procedure and cohort are novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Kırıkkale Univesity Faculty of Dentistry
    Kirikkale, Kırıkkale, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: Elif Çoban, DDS — Kırıkkale University Faculty of Dentistry
  • Study coordinator: Elif Assistant Professor, DDS
  • Email: elifcoban@kku.edu.tr
  • Phone: +90 318 224 4927

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.