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临床试验/NCT06605716
NCT06605716已完成不适用

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

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年2月1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
34
试验地点
2
主要终点
Heart rate monitoring

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Heart rate monitoring

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

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

Bedreddin Cavlı

Assistant Professor Doctor

Kutahya Health Sciences University

研究点 (2)

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