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ArrythmiaNCT02738567

Assessment of Adverse Cardiac Events Using Local Anesthesia With Adrenaline

An observational study of Arrythmia, run by Meir Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Arrythmia
What is being tested?
patients undergoing surgery or medical procedure
Type of treatment
Surgery or procedure
How many people
500 participants
Where
No sites listed yet
Study dates
Apr 2016to Mar 2017
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

About this study

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.

Read more

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
Being tested
patients undergoing surgery or medical procedure
Medical subject headings
Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patients undergoing surgery or medical procedureProcedure or surgery

Study groups in NCT02738567
Study groupRoleWhat they receive
local anesthesia with adrenalinepatients undergoing surgery or medical procedure with the use of local anesthesia with adrenaline
Receives: Procedure: patients undergoing surgery or medical procedure
local anesthesia without adrenalinepatients undergoing surgery or medical procedure with the use of local anesthesia without adrenaline
Receives: Procedure: patients undergoing surgery or medical procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of participants with arrythmia

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738567
Sponsor's protocol ID
0277-15-MMC
Status last verified
Mar 2016
First submitted
3 Apr 2016
Last updated
14 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Arrythmia, run by Meir Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of participants with arrythmia (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.

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