Ignite Creation Date:
2024-05-06 @ 1:25 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04029610
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2019-07-20
Brief Title:
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Sponsor:
Uri farkash
Organization:
Assuta Ashdod Hospital
Study Overview
Official Title:
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
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:
Goals 1 To check for frequency and type of arrhythmia in patients undergoing a medical procedure under local anesthesia 2 To examine whether the addition of adrenaline to local anesthesia affects the incidence of arrhythmias
Detailed Description:
Rationale Determining the frequency and type of arrhythmia will help determine the need for monitoring and the type of monitoring required during procedures under local anesthesia
Patients will undergo the prescribed medical procedure using local anesthesia Patients will be randomized into two groups Group 1 - Local anesthesia of lidocaine and arterial blockage on the arm Group 2 - Local anesthesia with lidocaine and adrenalin
The amount and type of anesthetic used shall be recorded In addition to the routine monitoring performed today use of non-invasive blood pressure gauge and oxygen saturation the patients will be connected to a cardiac holter monitor prior to the start of the surgical procedure and until they are released from the recovery room Upon completion of the monitoring the results of the holter test will be transmitted to the electrophysiology unit and analyzed to detect arrhythmias There will be a registration of side effects reported by patients which can result from arrhythmias palpitations dizziness fainting CPR In patients in whom arrhythmias are detected the type of arrhythmia and if it was accompanied by clinical symptoms will be recorded
Patients will undergo the prescribed medical procedure using local anesthesia Patients will be randomized into two groups Group 1 - Local anesthesia of lidocaine and arterial blockage on the arm Group 2 - Local anesthesia with lidocaine and adrenalin
The amount and type of anesthetic used shall be recorded In addition to the routine monitoring performed today use of non-invasive blood pressure gauge and oxygen saturation the patients will be connected to a cardiac holter monitor prior to the start of the surgical procedure and until they are released from the recovery room Upon completion of the monitoring the results of the holter test will be transmitted to the electrophysiology unit and analyzed to detect arrhythmias There will be a registration of side effects reported by patients which can result from arrhythmias palpitations dizziness fainting CPR In patients in whom arrhythmias are detected the type of arrhythmia and if it was accompanied by clinical symptoms will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None