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).
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
- Conditions the study is for
- Trigeminocardiac Reflex, Jaw Cysts, Hemodynamic Instability
- 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
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).
- Conditions
- Trigeminocardiac Reflex, Jaw Cysts, Hemodynamic Instability
- 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 group | Role | What they receive |
|---|---|---|
| Maxilla | Experimental | Presence of cystic structures larger than 1 cm in the maxilla with a surgical indication for enucleation Healthy adults Receives: Procedure: Enucleation of cysts |
| Mandibula | Experimental | Presence 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.
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
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
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.
- First posted20 Sep 2024
- Study start1 Feb 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminocardiac ReflexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedreddin Cavlı, Kutahya Health Sciences University
- Investigators
- Bedreddin Cavlı, Asst Prof, Principal investigator, Kutahya University of Health Sciences, Faculty of Dentistry
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations
- ClinicalTrials.gov ID
- NCT06605716
- Acronym / sponsor ID
- KutahyaHSU/BedreddinCavli/002
- Conditions
- Trigeminocardiac Reflex, Jaw Cysts, Hemodynamic Instability
- Keywords
- Trigemino-Cardiac Reflex, Jaw cysts, Hemodynamic instability,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxilla | Experimental | Procedure: Enucleation of cystsPresence of cystic structures larger than 1 cm in the maxilla with a surgical indication for enucleation Healthy adults |
| Mandibula | Experimental | Procedure: Enucleation of cystsPresence of cystic structures larger than 1 cm in the mandible with a surgical indication for enucleation Healthy adults |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding female patients
- Patients with systemic health problems
- Patients with mental or neurological disorders
- Patients taking antidepressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enucleation of cystsSurgical removal of cystic structures larger than 1 cm in patients included in the study arms. Patients were monitored for TCR during the procedure. | Procedure or surgery | Mandibula, Maxilla |
Primary outcome
Heart rate monitoring
Time frame: During the operation
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.
Systolic, and diastolic blood pressure monitoring
Time frame: During the operation
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.
Oxygen saturation monitoring
Time frame: During the operation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
Related trials for Trigeminocardiac Reflex
RecruitingObservational study
Hemodynamic Changes and Trigeminocardiac Reflex During Bimaxillary Orthognathic Surgery
Orthognathic Surgery, Trigeminocardiac Reflex
Recruiting
NASVAL-SVT: Nasal Swab Versus Modified Valsalva for Supraventricular Tachycardia
Supraventricular Tachycardia, Paroxysmal Supraventricular Tachycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bedreddin Cavlı, Asst Prof principal investigator
Kutahya University of Health Sciences, Faculty of Dentistry
1 site in 1 country: see every site and its status.
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.