Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics

Summary

Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more dangerous LA, especially in patients with increased cardiovascular risk. There is scarce clinical data about the safety of the use of hyaluronidase in dental procedures.

This study aimed to compare hemodynamic and electrocardiographic variables during a dental surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in healthy subjects.

Conditions

• Cardiac Arrhythmias

Interventions

DRUG

3.6mL 2% Mepivacaine with 1:100,000 epinephrine

Local anesthetic with vasoconstrictor

PROCEDURE

Lower Third Molar Extraction

Lower Third Molar Extraction with LA + hyaluronidase (or placebo)

DRUG

Hyaluronidase

75RTU Hyaluronidase administration concomitant to the local anesthetic

DRUG

Placebo

1mL 0.9% saline administration concomitant to the local anesthetic

Sponsors & Collaborators

• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

  collaborator OTHER_GOV

• Mauricio Jose Tornelli

  lead OTHER

Principal Investigators

• Gustavo F Prado, PhD · FMUSP

• Maria A Borsatti, PhD · FOUSP

• Rodney G Rocha, PhD · FOUSP

• Helena R Tornelli, MD, S · FOUSP

• Renata MS Prado, MS, S · FOUSP

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2007-10-31

Completion

2011-12-31

Countries

• Brazil

Study Locations