Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions

April 6, 2016 updated by: Fabio Ritto, Rio de Janeiro State University

Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations

The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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

13 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Class I patients according to the American Society of Anesthesiology (ASA),
  • Indication for third molars extraction,
  • Similar degree of complexity, according to the classification of Pell and Gregory.

Exclusion Criteria:

  • Patients with systemic conditions,
  • Patients with known allergy to any component of the anesthetic solution.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epinephrine 1:100,000
Inferior alveolar nerve block with Epinephrine 1:100.000
Drug: Epinephrine 1:100,000
Inferior alveolar nerve block with Epinephrine 1:100.000
Experimental: Epinephrine 1:200,000
Inferior alveolar nerve block with Epinephrine 1:200.000
Drug: Epinephrine 1:200,000
Inferior alveolar nerve block with Epinephrine 1:200.000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 20 minutes
20 minutes
Heart rate
Time Frame: 20 minutes
20 minutes
Arterial oxygen saturation, measured with a pulse oximeter device
Time Frame: 20 minutes
20 minutes
Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive
Time Frame: 20 minutes
20 minutes
Pain, evaluated using a visual analogue scale
Time Frame: After procedure, about 1 hour
After procedure, about 1 hour

Collaborators and Investigators

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

Sponsor

Rio de Janeiro State University

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

December 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 496.117

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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