Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations

The goal of this clinical trial is to investigate the frequency of trigeminocardiac reflex development during the surgical removal of large cystic structures within the maxillary and mandibular bones in healthy adults. The main questions it aims to answer are:

• What is the frequency of trigeminocardiac reflex development during the related surgical procedure?
• Does the frequency of TCR differ between the maxilla and mandible?
• Does the risk level for TCR increase in surgical procedures near vital structures (sinus floor, nasal floor, inferior alveolar nerve) depending on the size of the cyst?

Study Overview

• Status: Completed
• Conditions: Jaw Cysts; Hemodynamic Instability; Trigeminocardiac Reflex
• Intervention / Treatment: Procedure: Enucleation of cysts

Detailed Description

A total of 34 patients, including 17 undergoing maxillary and 17 undergoing mandibular cyst enucleations, were included in the study. Evaluation of the patients was performed using orthopantomogram films. The distances of the relevant cysts from surrounding vital structures were recorded, confirmed, and documented as necessary with cone beam computed tomography images if less than or greater than 1 mm.

Patients were divided into 2 groups, evenly comprising 17 patients each in maxilla and mandible groups. The surgeries included in the study were performed by a single surgeon. Surgical procedures utilized crestal incisions with horizontal and vertical relaxing incisions related to the size of the cysts.

The follow-up of the trigeminocardiac reflex (TKR) was conducted due to the occurrence of sudden bradycardia that was unprecedented following a tachycardia, which could develop within a few seconds and showed improvement when the procedure was paused. To ensure accurate and timely monitoring of this sudden process and to track potential asystole, patients were preferred to be monitored. Monitoring was facilitated using 5-channel Contec Medical Systems (Hebei, China) monitors. Throughout the procedure, heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure, and oxygen saturation were recorded.

The records were obtained during 6 separate surgical stages: firstly, during local anesthesia application; subsequently, during incision, flap elevation, removal of the bone barrier, manipulation and extraction of the cyst, irrigation, and suturing stages. Sudden changes occurring during the procedure were recorded along with their timing.

In defining TCR (Trigeminocardiac Reflex) in the literature, various reference measurement methods include sudden drops in heart rate by more than 10%, more than 20%, or dropping below 60 beats per minute. To highlight these different proportional reference drop values, severity grading was used in the observed TCR findings. Sudden drops in heart rate between 10% and 20% were classified as mild TCR (TKR-1), drops exceeding 20% and heart rate falling below 60 bpm as moderate TCR (TKR-2), and the presence of asystole, syncope, or need for atropine application as severe TCR (TCR-3). The total TCR across all grades was termed as t-TCR. TCR calculation was based on heart rate measurements taken at the beginning of each surgical stage.

To exclude vasovagal syncope, commonly cited as the most frequent cause of neurological emergencies, and high anxiety as etiological factors, patients initially underwent anxiety assessments. Individuals with high anxiety levels were excluded from the study. Patients' anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the State-Trait Anxiety Inventory-State (STAI-S).

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kütahya, Turkey, 43100
    • Kütahya University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients over 18 years of age
• Patients with cystic lesions at least 1 cm in diameter in the maxilla and mandible
• Patients with no systemic health problems

Exclusion Criteria:

• Pregnant or breastfeeding female patients
• Patients with systemic health problems
• Patients with mental or neurological disorders
• Patients taking antidepressants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maxilla; Presence of cystic structures larger than 1 cm in the maxilla with a surgical indication for enucleation Healthy adults	Procedure: Enucleation of cysts; Surgical removal of cystic structures larger than 1 cm in patients included in the study arms. Patients were monitored for TCR during the procedure.
Experimental: Mandibula; Presence of cystic structures larger than 1 cm in the mandible with a surgical indication for enucleation Healthy adults	Procedure: Enucleation of cysts; Surgical removal of cystic structures larger than 1 cm in patients included in the study arms. Patients were monitored for TCR during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate monitoring	All patients in all research arms monitored prior to enucleation of cystic structures in the maxilla and mandible had their heart rate monitored throughout the procedure.	During the operation
Systolic, and diastolic blood pressure monitoring	All patients in all research arms monitored prior to enucleation of cystic structures in the maxilla and mandible had their systolic, and diastolic blood pressure monitored throughout the procedure.	During the operation
Oxygen saturation monitoring	All patients in all research arms monitored prior to enucleation of cystic structures in the maxilla and mandible had their oxygen saturation monitored throughout the procedure.	During the operation

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Bedreddin Cavlı, Asst Prof, Kutahya University of Health Sciences, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Trigemino-Cardiac Reflex; Jaw cysts; Hemodynamic instability,
• Additional Relevant MeSH Terms: Neoplasms; Musculoskeletal Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Jaw Diseases; Bone Cysts; Cysts; Jaw Cysts
• Other Study ID Numbers: KutahyaHSU/BedreddinCavli/002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No