Association Between Lingual Retraction and Hemodynamic Changes in Patients Receiving Dental Treatment Under General Anesthesia

NCT07240688 | Completed

• 1 other identifier: KU-ERKAN-003
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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.\*\*

Conditions

Trigeminocardiac Reflex; Hemodynamic Changes; Dental Procedures

Keywords

Trigeminocardiac Reflex; Hemodynamic Changes; Lingual Retraction; Dental Procedures; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  During the dental procedure (up to 4 hours)

Secondary Outcomes (3)

• Incidence and Characteristics of TCR Events

  During the dental procedure (up to 4 hours)

• Association of TCR Events With Procedural and Anatomic Factors

  During the dental procedure (up to 4 hours)

• Influence of Patient Characteristics on TCR Occurrence

  During the dental procedure (up to 4 hours)

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients referred to our faculty for dental procedures requiring general anesthesia.
• Patients classified as ASA physical status I or II.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University, Faculty of Dentistry

Kırıkkale, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28728750 BACKGROUND

MeSH Terms

Conditions

Glossoptosis

Condition Hierarchy (Ancestors)

Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: October 13, 2025
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)