Assessment of Adverse Cardiac Events Using Local Anesthesia With Adrenaline

NCT02738567 | Unknown

• 1 other identifier: 0277-15-MMC
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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. 1.To examine the prevalence and types of arrhythmias in patients undergoing a medical procedure performed under local anesthesia
2. 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.

Conditions

Arrythmia

Outcome Measures

Primary Outcomes (1)

• number of participants with arrythmia

  day 1

Study Arms (2)

local anesthesia with adrenaline

patients undergoing surgery or medical procedure with the use of local anesthesia with adrenaline

Procedure: patients undergoing surgery or medical procedure

local anesthesia without adrenaline

patients undergoing surgery or medical procedure with the use of local anesthesia without adrenaline

Procedure: patients undergoing surgery or medical procedure

Interventions

patients undergoing surgery or medical procedure PROCEDURE

local anesthesia with adrenaline; local anesthesia without adrenaline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing surgery or a medical procedure in which a local anesthetic is used at Meir Hospital.

You may qualify if:

• patients undergoing surgery or a medical procedure in which a local anesthetic is used at Meir Hospital.

You may not qualify if:

• Patients with a medical history of known cardiac arrhythmia will not be included.

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 14, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 14, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share