Cardiac ArrhythmiasPhase 4NCT01719978
Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics
A Phase 4 study testing 3.6mL 2% Mepivacaine with 1:100,000 epinephrine, Lower Third Molar Extraction and Hyaluronidase in people with Cardiac Arrhythmias, run by Mauricio Jose Tornelli at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- 3.6mL 2% Mepivacaine with 1:100,000 epinephrine, Lower Third Molar Extraction and Hyaluronidase
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics: a Double-blind "Split-mouth" Controlled Trial.
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.
Read the detailed description
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
- Cardiac Arrhythmias
- Being tested
- 3.6mL 2% Mepivacaine with 1:100,000 epinephrine, Lower Third Molar Extraction, Hyaluronidase, Placebo
- Keywords
- Local Anaesthetics, Mepivacaine, hyaluronoglucosaminidase, Hemodynamic, Electrocardiography and Dentistry.
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.6mL 2% Mepivacaine with 1:100,000 epinephrineDrug
Also called Mepivacaine with epinephrine
Local anesthetic with vasoconstrictor
Lower Third Molar ExtractionProcedure or surgery
Also called Molar surgery
Lower Third Molar Extraction with LA + hyaluronidase (or placebo)
HyaluronidaseDrug
75RTU Hyaluronidase administration concomitant to the local anesthetic
PlaceboDrug
Also called Saline, 0.9% NaCl
1mL 0.9% saline administration concomitant to the local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronidase | Active comparator | Lower Third Molar Extraction -- 3.6mL 2% Mepivacaine with 1:100,000 epinephrine + Hyaluronidase Receives: Drug: 3.6mL 2% Mepivacaine with 1:100,000 epinephrine; Procedure: Lower Third Molar Extraction; Drug: 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) Receives: Drug: 3.6mL 2% Mepivacaine with 1:100,000 epinephrine; Procedure: Lower Third Molar Extraction; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia
Atrial or ventricular arrhythmias: isolated, paired or clustered extrasystoles, tachycardia, bradycardia and fibrillation.
Measured: 5min before anaesthesia
Secondary outcomes (5)
PR segment
- Duration of the PR segment, in milliseconds.
Measured: 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
- Duration of the QRS complex, in milliseconds.
Measured: 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
- Change from baseline Heart rate (evaluated period - baseline), in beats per minute. Values will be expressed as the absolute difference and the percentage of change.
Measured: 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
- Duration of the calculated corrected QT segment (QTc) in milliseconds.
Measured: 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)
- Heart rate, (absolute values) in beats per minute.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2007
- Primary completionOct 2007
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauricio Jose Tornelli
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor-investigator, Mauricio Jose Tornelli, University of Sao Paulo
- Investigators
- Gustavo F Prado, PhD, Study chair, FMUSPMaria A Borsatti, PhD, Study director, FOUSPRodney G Rocha, PhD, Study director, FOUSPHelena R Tornelli, MD, S, Study chair, FOUSPRenata MS Prado, MS, S, Study chair, FOUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719978
- Sponsor's protocol ID
- MTornelli
- Status last verified
- Oct 2012
- First submitted
- 3 Oct 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics: a Double-blind "Split-mouth" Controlled Trial.
- ClinicalTrials.gov ID
- NCT01719978
- Acronym / sponsor ID
- MTornelli
- Conditions
- Cardiac Arrhythmias
- Keywords
- Local Anaesthetics, Mepivacaine, hyaluronoglucosaminidase, Hemodynamic, Electrocardiography and Dentistry.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mauricio Jose TornelliUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Oct 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronidase | Active comparator | Drug: 3.6mL 2% Mepivacaine with 1:100,000 epinephrine, Procedure: Lower Third Molar Extraction, Drug: HyaluronidaseLower Third Molar Extraction -- 3.6mL 2% Mepivacaine with 1:100,000 epinephrine + Hyaluronidase |
| Placebo | Placebo comparator | Drug: 3.6mL 2% Mepivacaine with 1:100,000 epinephrine, Procedure: Lower Third Molar Extraction, Drug: PlaceboLower Third Molar Extraction -- Anesthetic: 3.6 mL of the LA 2% HCl mepivacaine with 1:100,000 epinephrine + Placebo (0.9% saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3.6mL 2% Mepivacaine with 1:100,000 epinephrineAlso: Mepivacaine with epinephrineLocal anesthetic with vasoconstrictor | Drug | Hyaluronidase, Placebo |
| Lower Third Molar ExtractionAlso: Molar surgeryLower Third Molar Extraction with LA + hyaluronidase (or placebo) | Procedure or surgery | Hyaluronidase, Placebo |
| Hyaluronidase75RTU Hyaluronidase administration concomitant to the local anesthetic | Drug | Hyaluronidase |
| PlaceboAlso: Saline, 0.9% NaCl1mL 0.9% saline administration concomitant to the local anesthetic | Drug | Placebo |
Primary outcome
Arrhythmia
Time frame: 5min before anaesthesia
Atrial or ventricular arrhythmias: isolated, paired or clustered extrasystoles, tachycardia, bradycardia and fibrillation.
5 secondary outcomes
PR segment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo F Prado, PhD study chair
FMUSP
Maria A Borsatti, PhD study director
FOUSP
Rodney G Rocha, PhD study director
FOUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3.6mL 2% Mepivacaine with 1:100,000 epinephrine, Lower Third Molar Extraction and Hyaluronidase in people with Cardiac Arrhythmias, run by Mauricio Jose Tornelli at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia (time frame: 5min before anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.