Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605716
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Frequency of Trigeminocardiac Reflex in Maxillary and Mandibular Cyst Operations
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None