Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia

April 16, 2024 updated by: Itamara Lucia Itagiba Neves, University of Sao Paulo General Hospital

Cardiovascular Events in Patients With Low Cardiac Output Undergoing Local Dental Anesthesia With and Without Epinephrine: Randomized, Double-blind Pilot Study

Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • Recruiting
        • Instituto do Coração HCFMUSP
        • Contact:
        • Principal Investigator:
          • Itamara LI Neves, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with advanced heart failure, in INTERMACS III using dobutamine at 5 to 20 µg/kg/minute due to low cardiac output syndrome
  • Presence of periodontal disease, in the 4th or 6th sextant with indication of supragingival and/or subgingival periodontal scaling;
  • Residual root or teeth with periodontal disease in the jaw, with simple extraction indicated.

Exclusion Criteria:

  • Patients with a ventricular assist device such as an intra-aortic balloon implanted less than 24 hours after the dental procedure or with extracorporeal membrane oxygenation (ECMO);
  • Using other inotropes;
  • On mechanical ventilation;
  • Continuously using a non-invasive ventilation mask;
  • In septic shock;
  • Presence of acute myocardial infarction <30 days;
  • Patients with terminal non-cardiac disease, cyanotic congenital heart disease or cardiomyopathies with arrhythmogenic potential (arrhythmogenic dysplasia, hypertrophic cardiomyopathy, non-compacted myocardium);
  • Pregnant women;
  • History of sudden death recovered < 1 month ago;
  • In the recent postoperative period of cardiac surgery (5 days);
  • Allergic to sodium bisulfite and methylparaben, preservatives of epinephrine and the anesthetic cartridge, respectively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Grupo de estudo (Lidocaine with epinephrine)
Anesthetic lidocaine 2% with epinephrine 1:100.000
Procedure: Anesthetic infiltration
Application of local dental anesthesia with two cartridges (3,6 mL) for dental procedures (tooth extraction or periodontal treatment) in patients with low cardiac output syndrome.
Active Comparator: Grupo controle (Lidocaine)
Anesthetic lidocaine 2%
Procedure: Anesthetic infiltration
Application of local dental anesthesia with two cartridges (3,6 mL) for dental procedures (tooth extraction or periodontal treatment) in patients with low cardiac output syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount ventricular and supraventricular arrhythmia
Time Frame: during dental procedures
Number of ventricular and supraventricular arrhythmias recorded using Holter
during dental procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCOSDental

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After thesis defense, the IPD will be available on the Portal Digital Library of Theses and Dissertations of the University of São Paulo (http://www.teses.usp.br/index.php?option=com_jumi&fileid=12&Itemid=77&lang=pt-br), in a PDF file.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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