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Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery

24. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

18

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Elif Assistant Professor, DDS
  • Telefonnummer: 71 +90 318 224 4927
  • E-post: elifcoban@kku.edu.tr

Studer Kontakt Backup

Studiesteder

  • Tyrkia (Türkiye)
    • Kırıkkale
      • Kirikkale, Kırıkkale, Tyrkia (Türkiye), 71450
        • Rekruttering
        • Kırıkkale Univesity Faculty of Dentistry
        • Ta kontakt med:
        • Hovedetterforsker:
          • Elif Çoban, DDS
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Patients undergoing bimaxillary orthognathic surgery
Patients undergoing bimaxillary orthognathic surgery under routine intraoperative monitoring.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Trigeminocardiac Reflex (TCR)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Systolic Blood Pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kırıkkale University

Etterforskere

  • Hovedetterforsker: Elif Çoban, DDS, Kırıkkale University Faculty of Dentistry

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. juni 2026

Primær fullføring (Antatt)

20. juni 2027

Studiet fullført (Antatt)

20. juli 2027

Datoer for studieregistrering

Først innsendt

21. juli 2026

Først innsendt som oppfylte QC-kriteriene

21. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Decision No: 2026.04.66

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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