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Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics

NCT ID: NCT01719978

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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This double-blind crossover "split-mouth" trial evaluated the cardiovascular effects induced by 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine, concomitantly with 75 TRU/mL hyaluronidase or placebo in inferior alveolar nerve block, for the performance of bilateral and symmetrical third molar surgery in 20 outpatients. Cardiovascular parameters, including systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR), were monitored using oscillometric and photoplethysmographic methods in 10 clinical stages. Electrocardiographic records (ECG) of 12 leads were obtained in four steps. Hyaluronidase injected concomitantly with LA did not induce changes in SBP, DBP and HR compared to placebo. There were no instances of ST segment depression, ST segment elevation, wide QRS complex extrasystoles, or narrow QRS complex extrasystoles.

To date, few studies in dentistry have investigated the effects of local anaesthetic efficacy in hyaluronidase, and even fewer have studied the relation to systemic effects induced by this interaction.

The use of LA injected concomitantly with 75 TRU/mL of hyaluronidase is safe when using this dose and route of administration.

Clinical Relevance: In dentistry, few studies have investigated the effects of hyaluronidase on local anaesthetic efficacy, and even fewer have examined the possible systemic effects induced by this interaction.

Conditions

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Cardiac Arrhythmias

Keywords

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Local Anaesthetics Mepivacaine hyaluronoglucosaminidase Hemodynamic Electrocardiography and Dentistry.

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hyaluronidase

Lower Third Molar Extraction -- 3.6mL 2% Mepivacaine with 1:100,000 epinephrine + Hyaluronidase

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Local anesthetic with vasoconstrictor

Lower Third Molar Extraction

Intervention Type PROCEDURE

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

Hyaluronidase

Intervention Type DRUG

75RTU Hyaluronidase administration concomitant to the local anesthetic

Placebo

Lower Third Molar Extraction -- Anesthetic: 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine + Placebo (0.9% saline)

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

Local anesthetic with vasoconstrictor

Lower Third Molar Extraction

Intervention Type PROCEDURE

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

Placebo

Intervention Type DRUG

1mL 0.9% saline administration concomitant to the local anesthetic

Interventions

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

Local anesthetic with vasoconstrictor

Intervention Type DRUG

Lower Third Molar Extraction

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

Intervention Type PROCEDURE

Hyaluronidase

75RTU Hyaluronidase administration concomitant to the local anesthetic

Intervention Type DRUG

Placebo

1mL 0.9% saline administration concomitant to the local anesthetic

Intervention Type DRUG

Other Intervention Names

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Mepivacaine with epinephrine Molar surgery Saline 0.9% NaCl

Eligibility Criteria

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Inclusion Criteria

* Patients should present bilateral lower third molars (teeth 38 and 48) for extraction and identical anatomical arrangement;
* Absence of significant clinical morbidities, ASA I (American Society of Anesthesiologists, 1963);
* Aged over 18 years.

Exclusion Criteria

* Women during pregnancy or lactation;
* Smokers;
* History of sensitivity to any drug used in the research;
* Presence or history of cancer or an infectious lesion;
* Individuals who used any medication in the last 15 days (except oral contraceptives);
* Presence of abscess or pericoronitis in the region to be operated;
* Patients who required supplemental anaesthesia upon anaesthetic block of the inferior alveolar nerve (post-randomisation exclusion).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Mauricio Jose Tornelli

OTHER

Sponsor Role lead

Responsible Party

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Mauricio Jose Tornelli

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gustavo F Prado, PhD

Role: STUDY_CHAIR

FMUSP

Maria A Borsatti, PhD

Role: STUDY_DIRECTOR

FOUSP

Rodney G Rocha, PhD

Role: STUDY_DIRECTOR

FOUSP

Helena R Tornelli, MD, S

Role: STUDY_CHAIR

FOUSP

Renata MS Prado, MS, S

Role: STUDY_CHAIR

FOUSP

Locations

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Stomatology Department, FOUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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MTornelli

Identifier Type: -

Identifier Source: org_study_id