drugset / Trial / NCT01719978
Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics
Phase 4
Completed
20 enrolled
Mauricio Jose Tornelli
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. · collab
Non-randomizedSingle-groupDouble-blindTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2007-10
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | rHuPH20 | Protein / enzyme biologic | 75 unknown | Other |
| Comparator | Epinephrine | Other / unclassified | — | Other |
| Comparator | Mepivacaine | Other / unclassified | 3.6 ml | Other |