drugset / Trial / NCT01719978

Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics

NCT01719978

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

EvaluationDrugModalityDoseRoute
Comparator rHuPH20 Protein / enzyme biologic 75 unknown Other
Comparator Epinephrine Other / unclassified Other
Comparator Mepivacaine Other / unclassified 3.6 ml Other