Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery

NCT07726251 | Recruiting

• 1 other identifier: Decision No: 2026.04.66
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Orthognathic Surgery; Trigeminocardiac Reflex; Hemodynamic

Keywords

Trigeminocardiac Reflex; Bimaxillary Orthognathic Surgery; Hemodynamic Changes; Intraoperative Complications; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• 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

  During surgery

Secondary Outcomes (4)

• Systolic Blood Pressure

  During surgery

• Diastolic Blood Pressure

  During surgery

• Heart Rate

  During surgery

• Peripheral Oxygen Saturation

  During surgery

Study Arms (1)

Patients undergoing bimaxillary orthognathic surgery

Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale Univesity Faculty of Dentistry

Kirikkale, Kırıkkale, 71450, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elif Çoban, DDS

  Kırıkkale University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Assistant Professor, DDS

CONTACT

+90 318 224 4927; elifcoban@kku.edu.tr

Mert Research Asistant, DDS

CONTACT

+90 318 2244927; bilgim979899@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: June 20, 2026
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)