Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-31 @ 8:21 PM
Study NCT ID:
NCT02738567
Status:
UNKNOWN
Last Update Posted:
2016-04-14
First Post:
2016-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Adverse Cardiac Events Using Local Anesthesia With Adrenaline
Sponsor:
Meir Medical Center
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of vasopressor supplement materials to local anesthetics is commonly used in procedures in various fields of dentistry, ENT (ear, nose, and throat), Plastic Surgery, Hand surgery and gastroenterology. Epinephrine is used to constrict small blood vessels, thus reducing bleeding during a medical procedure, reducing the toxicity by reducing systemic absorption of local anesthetic, and prolonging the duration and intensity of neural blockage created by the local anesthetic.
There are descriptions in the literature of cases in which the use of lidocain and adrenaline caused adverse cardiac events such as arrhythmias, edema and increase in blood pressure during ENT and dentistry procedures. As far as we know there has never been a systematic examination of the incidence and severity of arrhythmias during procedures with local anesthesia.
The purpose of the study:
1. To examine the prevalence and types of arrhythmias in patients undergoing a medical procedure performed under local anesthesia
2. Examine whether adding adrenaline to the local anesthetics affects the incidence of arrhythmia Determining the prevalence and types of arrhythmia will help determine the need for monitoring and type of monitoring required during procedures under local anesthesia.
The patients:
500 patients undergoing surgery or a medical procedure in which a local anesthetic is used at Meir Hospital. Patients with a medical history of known cardiac arrhythmia will not be included.
Methods:
Patients will undergo the medical procedure prescribed for them, using local anesthesia with or without adrenaline, at the discretion of the surgeon, in accordance with the usual routine being applied nowadays. The amount and type of anesthesia used will be registered. In addition to the routine monitoring that is currently performed (blood pressure cuff and non-invasive blood oxygen saturation) a continuous ECG monitoring device will be connected prior to the beginning of the surgical procedure, until the patient is discharged from the recovery room. The ECG monitoring results will be analyzed to detect arrhythmia. Side effects being reported by patients (palpitations, dizziness, fainting, CPR {cardiopulmonary resuscitation} ) will be recorded. In cases that an arrhythmia is detected, the type of arrhythmia and the presence of clinical symptoms will be investigated.
There are descriptions in the literature of cases in which the use of lidocain and adrenaline caused adverse cardiac events such as arrhythmias, edema and increase in blood pressure during ENT and dentistry procedures. As far as we know there has never been a systematic examination of the incidence and severity of arrhythmias during procedures with local anesthesia.
The purpose of the study:
1. To examine the prevalence and types of arrhythmias in patients undergoing a medical procedure performed under local anesthesia
2. Examine whether adding adrenaline to the local anesthetics affects the incidence of arrhythmia Determining the prevalence and types of arrhythmia will help determine the need for monitoring and type of monitoring required during procedures under local anesthesia.
The patients:
500 patients undergoing surgery or a medical procedure in which a local anesthetic is used at Meir Hospital. Patients with a medical history of known cardiac arrhythmia will not be included.
Methods:
Patients will undergo the medical procedure prescribed for them, using local anesthesia with or without adrenaline, at the discretion of the surgeon, in accordance with the usual routine being applied nowadays. The amount and type of anesthesia used will be registered. In addition to the routine monitoring that is currently performed (blood pressure cuff and non-invasive blood oxygen saturation) a continuous ECG monitoring device will be connected prior to the beginning of the surgical procedure, until the patient is discharged from the recovery room. The ECG monitoring results will be analyzed to detect arrhythmia. Side effects being reported by patients (palpitations, dizziness, fainting, CPR {cardiopulmonary resuscitation} ) will be recorded. In cases that an arrhythmia is detected, the type of arrhythmia and the presence of clinical symptoms will be investigated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: