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Trigeminocardiac ReflexNCT06605716

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

A study testing Enucleation of cysts in people with Trigeminocardiac Reflex and Jaw Cysts, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Enucleation of cysts
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2023to 1 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kutahya University of Health Sciences

    Kütahya, 43100

Other trials in Turkey (Türkiye)

About this study

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?
Read the 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).

Being tested
Enucleation of cysts
Keywords
Trigemino-Cardiac Reflex, Jaw cysts, Hemodynamic instability,
Medical subject headings
Jaw Cysts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enucleation of cystsProcedure or surgery

    Surgical removal of cystic structures larger than 1 cm in patients included in the study arms. Patients were monitored for TCR during the procedure.

Study groups in NCT06605716
Study groupRoleWhat they receive
MaxillaExperimentalPresence of cystic structures larger than 1 cm in the maxilla with a surgical indication for enucleation Healthy adults
Receives: Procedure: Enucleation of cysts
MandibulaExperimentalPresence of cystic structures larger than 1 cm in the mandible with a surgical indication for enucleation Healthy adults
Receives: Procedure: Enucleation of cysts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the operation

  2. 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.

    Measured: During the operation

  3. 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.

    Measured: During the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2024
  2. Study start1 Feb 2023
  3. Primary completion1 Nov 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06605716
Sponsor's protocol ID
KutahyaHSU/BedreddinCavli/002
Status last verified
Sep 2024
First submitted
8 Jul 2024
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Enucleation of cysts in people with Trigeminocardiac Reflex and Jaw Cysts, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart rate monitoring (time frame: During the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.

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