Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mauricio Jose Tornelli
• Collaborator: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Treatments: Anesthetics; Anesthetics, Local; Epinephrine; Epinephryl borate; Mepivacaine; Racepinephrine

Criteria

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).