Observational Evaluation of Hemodynamic Parameters Using Routine Intraoperative Monitoring Data in Patients Undergoing Bimaxillary Orthognathic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Occurrence of Trigeminocardiac Reflex (TCR)
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Patients undergoing bimaxillary orthognathic surgery
Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring.
Outcomes
Primary Outcomes
Occurrence of Trigeminocardiac Reflex (TCR)
Time Frame: During surgery
Hemodynamic parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and peripheral oxygen saturation, recorded at 5-minute intervals during surgery will be evaluated in relation to the different stages of bimaxillary orthognathic surgery. In addition, the association of these hemodynamic changes with patient demographic characteristics and the occurrence of the trigeminocardiac reflex (TCR) will be analyzed.
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
- Heart Rate(During surgery)
- Systolic Blood Pressure(During surgery)
- Diastolic Blood Pressure(During surgery)
- Peripheral Oxygen Saturation(During surgery)
Investigators
Elif Çoban
Assistant Professor
Kırıkkale University