跳至主要内容
临床试验/NCT07240688
NCT07240688已完成不适用

A Prospective Observational Study on the Association of Lingual Retraction With Hemodynamic Parameter Changes in Patients Receiving Dental Procedures Under General Anesthesia

Kırıkkale University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2025年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Hemodynamic Changes Associated with Lingual Retraction

研究概览

简要总结

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.**

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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).

研究组 & 干预措施

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.

Group 2. Adult Patients

**Enrollment for this arm was terminated following the protocol amendment approved by the Ethics Committee to focus exclusively on pediatric autonomic responses.**

结局指标

主要结局

Hemodynamic Changes Associated with Lingual Retraction

时间窗: 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.

次要结局

  • 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))

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gözde Nur Erkan

Assistant Professor, MD

Kırıkkale University

研究点 (1)

Loading locations...

相似试验