Assessment of Adverse Cardiac Events Using Local Anesthesia With Adrenaline

NCT ID: NCT02738567

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-03-31

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.

Conditions

Arrythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

local anesthesia with adrenaline

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

patients undergoing surgery or medical procedure

Intervention Type: PROCEDURE

local anesthesia without adrenaline

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

patients undergoing surgery or medical procedure

Intervention Type: PROCEDURE

Interventions

patients undergoing surgery or medical procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0277-15-MMC

Identifier Type: -

Identifier Source: org_study_id