Trigeminocardiac ReflexNCT07240688
Association Between Lingual Retraction and Hemodynamic Changes in Patients Receiving Dental Treatment Under General Anesthesia
An observational study of Trigeminocardiac Reflex and Hemodynamic Changes, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the association between sudden decreases in heart rate and blood pressure during dental procedures requiring lingual retraction-such as fillings, root canal treatments, tooth extractions, and cyst surgeries-under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Trigeminocardiac Reflex, Hemodynamic Changes, Dental Procedures
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Oct 2025to 27 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients undergoing dental procedures under general anesthesia at Kırıkkale University, Faculty of Dentistry, aged 2-18, classified as ASA physical status I or II. Pediatric patients will be included. Patients with cardiac or neurological conditions affecting the trigeminocardiac reflex will be excluded.
Who may be able to join
- Patients referred to our faculty for dental procedures requiring general anesthesia.
- Patients classified as ASA physical status I or II.
Who cannot join
- Patients unwilling to participate in the study.
- Patients classified as ASA physical status III or IV.
- Patients with diseases affecting cardiac inotropy, chronotropy, or dromotropy.
- Patients using medications influencing cardiac inotropy, chronotropy, or dromotropy.
- Patients with cardiac pacemakers.
- Patients with cardiac arrhythmias.
- Patients with neurological disorders affecting the trigeminocardiac reflex pathway (inhibition or activation).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University, Faculty of Dentistry
Kirikkale
About this study
Official title: A Prospective Observational Study on the Association of Lingual Retraction With Hemodynamic Parameter Changes in Patients Receiving Dental Procedures Under General Anesthesia
This study aims to investigate the association between sudden decreases in heart rate and blood pressure during dental procedures requiring lingual retraction-such as fillings, root canal treatments, tooth extractions, and cyst surgeries-under general anesthesia. Patients will be routinely monitored for vital parameters during anesthesia. Sudden drops in heart rate and blood pressure (10-20% decrease) will be recorded as lingual retraction-related trigeminocardiac reflex (TCR) events, along with the type of lingual retraction, dental procedure, and tooth location at the time of occurrence. Additionally, the results will be analyzed in relation to patient age, sex, and tongue size.
Amendment [March 2026]: Following protocol revision and ethics committee approval, the study population has been restricted to pediatric patients (aged 2-18 years), and the adult arm has been discontinued. The primary outcome and observational methodology remain unchanged; however, the secondary outcome regarding adult-pediatric comparison has been removed from the analysis plan.**
Read the detailed description
Stimulation of both the central and peripheral branches of the trigeminal nerve can lead to clinically significant hemodynamic changes. The trigeminocardiac reflex (TCR), a brainstem-mediated reflex mechanism triggered by such stimulations, causes sudden and marked decreases in heart rate and arterial blood pressure. This reflex may result in hemodynamic instability during surgical interventions and, in rare cases, can precipitate severe cardiac complications including cardiac arrest.
While TCR is more commonly observed during ophthalmic, craniofacial, and skull base surgeries, it may also occur during dental procedures. Stimulation of the peripheral branches of the lingual nerve, such as during lingual retraction, has been associated with cardiovascular side effects like bradycardia. This phenomenon reflects systemic hemodynamic responses resulting from trigeminal nerve stimulation.
The literature reports significant drops in heart rate and arterial pressure due to TCR during common dental procedures such as tooth extraction and implant surgery. Notably, sudden decreases of 10-20% in blood pressure are considered clinically relevant indicators of TCR. Additionally, hemodynamic changes potentially related to this reflex have been documented during endodontic treatments, particularly in cases of irreversible pulpitis. Thus, stimulation of the dental branches of the trigeminal nerve may trigger TCR during dental procedures, leading to systemic hypotension.
In conclusion, TCR triggered by trigeminal nerve stimulation is an important hemodynamic reflex encountered during surgical and dental interventions. Early recognition and appropriate preventive measures are critical to mitigating potential cardiac risks. Clinical procedures should consider patients' susceptibility to such reflexes in planning and management.
This study aims to investigate the incidence of trigeminocardiac reflex triggered primarily by lingual retraction, and secondarily by dental procedure type, tooth location, patient age, and duration of general anesthesia in pediatric patients undergoing dental surgeries under general anesthesia. Statistical Revision \& Amendment [March 2026]: The study protocol has been revised to focus exclusively on the pediatric population (aged 2-18 years), in line with the primary research objective. The initial design included both adult (n=50) and pediatric (n=50) cohorts; however, the pediatric cohort was prioritized due to its greater susceptibility to trigeminocardiac reflex (TCR) events, and practical considerations regarding adult enrollment feasibility. Consequently, the adult arm was discontinued. This modification was reviewed and formally approved by the Kırıkkale University Non-Interventional Research Ethics Committee in its meeting on March 11, 2026 (2026/04 meeting number), referencing the original approval of the study (2025/12 meeting number, decision 2025.09.04). The primary outcome and data collection methodology from the original protocol were preserved, while the previously planned secondary outcome comparing adult and pediatric cohorts was removed. No other aspects of study design, observational methods, or ethical standards were modified.
Sample size calculations were performed using two complementary approaches. First, for multivariable analysis of potential predictors-including age, sex, anesthesia-related factors, and dental procedure characteristics (procedure type and the presence or absence of lingual retraction or tongue-base pressure)-sample size was calculated using the 'pwr' package in R Statistical Software (v4.5.2). Assuming a medium effect size (f² = 0.15), α = 0.05, and power = 0.80, the required total sample size was confirmed as N = 85.
Second, a proportion-based calculation was conducted to estimate the required pediatric sample size for detecting clinically relevant TCR-related hemodynamic responses (≥10% reduction in MABP). While prior literature reports a TCR incidence of approximately 52% in adults , a higher incidence of 70% was projected for pediatric patients due to their increased clinical sensitivity. The corresponding Cohen's h for this comparison was 0.34. This approach indicated that at least 68 participants would be required (α = 0.05, power = 0.80), but to ensure adequate statistical power across all analyses, the final sample size was set at N = 85.
Following the discontinuation of the adult cohort in March 2026, the statistical analysis plan was refined to prioritize a high-powered, single-cohort evaluation of the pediatric population. The removal of the adult-pediatric comparative analysis (previously a secondary objective) does not affect the internal validity of the primary outcome. All multivariable models and proportion-based estimates have been re-calibrated for the pediatric target sample of N=85, ensuring that the study remains adequately powered to identify key predictors of TCR events in this specific high-sensitivity group** Conducted at the operating rooms of Kırıkkale University Faculty of Dentistry, this prospective observational study will record TCR events using a specially designed patient monitoring form, correlating these events with various clinical factors.
- Keywords
- Trigeminocardiac Reflex, Hemodynamic Changes, Lingual Retraction, Dental Procedures, General Anesthesia
- Medical subject headings
- Glossoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Pediatric Patients | Patients aged 0 to 18 years undergoing dental procedures under general anesthesia. No intervention beyond routine clinical care; observational monitoring of trigeminocardiac reflex and hemodynamic parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Changes Associated with Lingual Retraction
To quantify acute intraoperative alterations in heart rate and blood pressure related to lingual retraction during dental procedures performed under general anesthesia. Sudden decreases of ≥10-20% in these parameters will be defined and recorded as trigeminocardiac reflex (TCR) events.
Measured: During the dental procedure (up to 4 hours)
Secondary outcomes (3)
Incidence and Characteristics of TCR Events
To determine the overall incidence of lingual retraction-related TCR events and to characterize their severity and duration, including the magnitude of hemodynamic change and the need for pharmacologic or mechanical interventions.
Measured: During the dental procedure (up to 4 hours)
Association of TCR Events With Procedural and Anatomic Factors
To evaluate the relationship between TCR occurrence and (a) the type of dental procedure (e.g., filling, root canal treatment, extraction, cyst surgery), (b) the method of lingual retraction, and (c) the treated tooth location (anterior/posterior; maxillary/mandibular).
Measured: During the dental procedure (up to 4 hours)
Influence of Patient Characteristics on TCR Occurrence
To investigate the association between patient-specific factors-such as age, sex, and tongue size-and the likelihood of developing TCR during lingual retraction under general anesthesia.
Measured: During the dental procedure (up to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start13 Oct 2025
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Nur Erkan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240688
- Sponsor's protocol ID
- KU-ERKAN-003
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available but may be shared upon reasonable request with qualified researchers, subject to approval by the study team and compliance with ethical and confidentiality guidelines.
Publications
Huang JI, Chang HH, Lin CP, Liao WC, Kao CT, Huang TH. Trigeminocardiac reflex during non-surgical root canal treatment of teeth with irreversible pulpitis. J Formos Med Assoc. 2018 Jun;117(6):512-517. doi: 10.1016/j.jfma.2017.05.010. Epub 2017 Jul 17.
PubMed 28728750
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Association of Lingual Retraction With Hemodynamic Parameter Changes in Patients Receiving Dental Procedures Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07240688
- Acronym / sponsor ID
- KU-ERKAN-003
- Keywords
- Trigeminocardiac Reflex, Hemodynamic Changes, Lingual Retraction, Dental Procedures, General Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 21 Nov 2025 (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.
This study aims to investigate the association between sudden decreases in heart rate and blood pressure during dental procedures requiring lingual retraction-such as fillings, root canal treatments, tooth extractions, and cyst surgeries-under general anesthesia. Patients will be routinely monitored for vital parameters during anesthesia. Sudden drops in heart rate and blood pressure (10-20% decrease) will be recorded as lingual retraction-related trigeminocardiac reflex (TCR) events, along with the type of lingual retraction, dental procedure, and tooth location at the time of occurrence. Additionally, the results will be analyzed in relation to patient age, sex, and tongue size.
Amendment [March 2026]: Following protocol revision and ethics committee approval, the study population has been restricted to pediatric patients (aged 2-18 years), and the adult arm has been discontinued. The primary outcome and observational methodology remain unchanged; however, the secondary outcome regarding adult-pediatric comparison has been removed from the analysis plan.**
Detailed description
Stimulation of both the central and peripheral branches of the trigeminal nerve can lead to clinically significant hemodynamic changes. The trigeminocardiac reflex (TCR), a brainstem-mediated reflex mechanism triggered by such stimulations, causes sudden and marked decreases in heart rate and arterial blood pressure. This reflex may result in hemodynamic instability during surgical interventions and, in rare cases, can precipitate severe cardiac complications including cardiac arrest.
While TCR is more commonly observed during ophthalmic, craniofacial, and skull base surgeries, it may also occur during dental procedures. Stimulation of the peripheral branches of the lingual nerve, such as during lingual retraction, has been associated with cardiovascular side effects like bradycardia. This phenomenon reflects systemic hemodynamic responses resulting from trigeminal nerve stimulation.
The literature reports significant drops in heart rate and arterial pressure due to TCR during common dental procedures such as tooth extraction and implant surgery. Notably, sudden decreases of 10-20% in blood pressure are considered clinically relevant indicators of TCR. Additionally, hemodynamic changes potentially related to this reflex have been documented during endodontic treatments, particularly in cases of irreversible pulpitis. Thus, stimulation of the dental branches of the trigeminal nerve may trigger TCR during dental procedures, leading to systemic hypotension.
In conclusion, TCR triggered by trigeminal nerve stimulation is an important hemodynamic reflex encountered during surgical and dental interventions. Early recognition and appropriate preventive measures are critical to mitigating potential cardiac risks. Clinical procedures should consider patients' susceptibility to such reflexes in planning and management.
This study aims to investigate the incidence of trigeminocardiac reflex triggered primarily by lingual retraction, and secondarily by dental procedure type, tooth location, patient age, and duration of general anesthesia in pediatric patients undergoing dental surgeries under general anesthesia. Statistical Revision \& Amendment [March 2026]: The study protocol has been revised to focus exclusively on the pediatric population (aged 2-18 years), in line with the primary research objective. The initial design included both adult (n=50) and pediatric (n=50) cohorts; however, the pediatric cohort was prioritized due to its greater susceptibility to trigeminocardiac reflex (TCR) events, and practical considerations regarding adult enrollment feasibility. Consequently, the adult arm was discontinued. This modification was reviewed and formally approved by the Kırıkkale University Non-Interventional Research Ethics Committee in its meeting on March 11, 2026 (2026/04 meeting number), referencing the original approval of the study (2025/12 meeting number, decision 2025.09.04). The primary outcome and data collection methodology from the original protocol were preserved, while the previously planned secondary outcome comparing adult and pediatric cohorts was removed. No other aspects of study design, observational methods, or ethical standards were modified.
Sample size calculations were performed using two complementary approaches. First, for multivariable analysis of potential predictors-including age, sex, anesthesia-related factors, and dental procedure characteristics (procedure type and the presence or absence of lingual retraction or tongue-base pressure)-sample size was calculated using the 'pwr' package in R Statistical Software (v4.5.2). Assuming a medium effect size (f² = 0.15), α = 0.05, and power = 0.80, the required total sample size was confirmed as N = 85.
Second, a proportion-based calculation was conducted to estimate the required pediatric sample size for detecting clinically relevant TCR-related hemodynamic responses (≥10% reduction in MABP). While prior literature reports a TCR incidence of approximately 52% in adults , a higher incidence of 70% was projected for pediatric patients due to their increased clinical sensitivity. The corresponding Cohen's h for this comparison was 0.34. This approach indicated that at least 68 participants would be required (α = 0.05, power = 0.80), but to ensure adequate statistical power across all analyses, the final sample size was set at N = 85.
Following the discontinuation of the adult cohort in March 2026, the statistical analysis plan was refined to prioritize a high-powered, single-cohort evaluation of the pediatric population. The removal of the adult-pediatric comparative analysis (previously a secondary objective) does not affect the internal validity of the primary outcome. All multivariable models and proportion-based estimates have been re-calibrated for the pediatric target sample of N=85, ensuring that the study remains adequately powered to identify key predictors of TCR events in this specific high-sensitivity group** Conducted at the operating rooms of Kırıkkale University Faculty of Dentistry, this prospective observational study will record TCR events using a specially designed patient monitoring form, correlating these events with various clinical factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1. Pediatric Patients | – | –Patients aged 0 to 18 years undergoing dental procedures under general anesthesia. No intervention beyond routine clinical care; observational monitoring of trigeminocardiac reflex and hemodynamic parameters. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients undergoing dental procedures under general anesthesia at Kırıkkale University, Faculty of Dentistry, aged 2-18, classified as ASA physical status I or II. Pediatric patients will be included. Patients with cardiac or neurological conditions affecting the trigeminocardiac reflex will be excluded.
Key inclusion criteria (2 listed)
- Patients referred to our faculty for dental procedures requiring general anesthesia.
- Patients classified as ASA physical status I or II.
Key exclusion criteria (7 listed)
- Patients unwilling to participate in the study.
- Patients classified as ASA physical status III or IV.
- Patients with diseases affecting cardiac inotropy, chronotropy, or dromotropy.
- Patients using medications influencing cardiac inotropy, chronotropy, or dromotropy.
- Patients with cardiac pacemakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemodynamic Changes Associated with Lingual Retraction
Time frame: During the dental procedure (up to 4 hours)
To quantify acute intraoperative alterations in heart rate and blood pressure related to lingual retraction during dental procedures performed under general anesthesia. Sudden decreases of ≥10-20% in these parameters will be defined and recorded as trigeminocardiac reflex (TCR) events.
3 secondary outcomes
Incidence and Characteristics of TCR Events
Time frame: During the dental procedure (up to 4 hours)
Association of TCR Events With Procedural and Anatomic Factors
Time frame: During the dental procedure (up to 4 hours)
Influence of Patient Characteristics on TCR Occurrence
Time frame: During the dental procedure (up to 4 hours)
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 9 Apr 2026.
- Background: PubMed 28728750Huang JI, Chang HH, Lin CP, Liao WC, Kao CT, Huang TH. Trigeminocardiac reflex during non-surgical root canal treatment of teeth with irreversible pulpitis. J Formos Med Assoc. 2018 Jun;117(6):512-517. doi: 10.1016/j.jfma.2017.05.010. Epub 2017 Jul 17.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available but may be shared upon reasonable request with qualified researchers, subject to approval by the study team and compliance with ethical and confidentiality guidelines.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminocardiac Reflex and Hemodynamic Changes, run by Kırıkkale 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 2 inclusion and 7 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 9 Apr 2026. 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?
Hemodynamic Changes Associated with Lingual Retraction (time frame: During the dental procedure (up to 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240688, which also lists 1 linked publication.
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 9 Apr 2026.