NCT01719978

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
Last Updated

November 2, 2012

Status Verified

October 1, 2012

Enrollment Period

Same day

First QC Date

October 3, 2012

Last Update Submit

October 31, 2012

Conditions

Cardiac Arrhythmias

Keywords

Local AnaestheticsMepivacainehyaluronoglucosaminidaseHemodynamicElectrocardiography and Dentistry.

Outcome Measures

Primary Outcomes (1)

  • Arrhythmia

    Atrial or ventricular arrhythmias: isolated, paired or clustered extrasystoles, tachycardia, bradycardia and fibrillation.

    5min before anaesthesia

Secondary Outcomes (5)

  • PR segment

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

  • QRS complex

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

  • Change from baseline Heart rate

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

  • Corrected QT

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

  • Heart rate (absolute values)

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

Other Outcomes (6)

  • Systolic Pressure (absolute values)

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

  • Diastolic Pressure (absolute values)

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

  • Mean Blood Pressure (absolute values)

    5min before anaesthesia; During anaesthetic injection; 5min after anaesthesia; Incision; Syndesmotomy; Luxation; Avulsion; Curetage; Suture; 1 hour after the end of surgery (At Patient discharge) and in the 7th postoperative day

  • +3 more other outcomes

Study Arms (2)

Hyaluronidase

ACTIVE COMPARATOR

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

Drug: 3.6mL 2% Mepivacaine with 1:100,000 epinephrineProcedure: Lower Third Molar ExtractionDrug: Hyaluronidase

Placebo

PLACEBO COMPARATOR

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

Drug: 3.6mL 2% Mepivacaine with 1:100,000 epinephrineProcedure: Lower Third Molar ExtractionDrug: Placebo

Interventions

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

Local anesthetic with vasoconstrictor

Also known as: Mepivacaine with epinephrine
HyaluronidasePlacebo
Lower Third Molar ExtractionPROCEDURE

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

Also known as: Molar surgery
HyaluronidasePlacebo
HyaluronidaseDRUG

75RTU Hyaluronidase administration concomitant to the local anesthetic

Hyaluronidase
PlaceboDRUG

1mL 0.9% saline administration concomitant to the local anesthetic

Also known as: Saline, 0.9% NaCl
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stomatology Department, FOUSP

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

MepivacaineEpinephrineHyaluronoglucosaminidaseSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsGlycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyasesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Gustavo F Prado, PhD

    FMUSP

    STUDY CHAIR

  • Maria A Borsatti, PhD

    FOUSP

    STUDY DIRECTOR

  • Rodney G Rocha, PhD

    FOUSP

    STUDY DIRECTOR

  • Helena R Tornelli, MD, S

    FOUSP

    STUDY CHAIR

  • Renata MS Prado, MS, S

    FOUSP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 3, 2012

First Posted

November 1, 2012

Study Start

October 1, 2007

Primary Completion

October 1, 2007

Study Completion

December 1, 2011

Last Updated

November 2, 2012

Record last verified: 2012-10

Locations

BR(1)