Rhinoplasty Clinical Trial
Official title:
Comparative Evaluation of Cocaine and Adrenaline as Topical Vasonconstrictor Agents in Cosmetic Rhinoplasty
This study aims to compare two vasoconstrictive agents topically applied in cosmetic rhinoplasty: cocaine HCl 5% and adrenaline 1:1000. Blood loss during surgery as well as systemic effect of the studied agents are evaluated.
A prospective non-randomized study is conducted. Female patients undergoing cosmetic
rhinoplasty are included in the study.
All procedures are performed by two surgeons, both with more than ten years of experience in
cosmetic rhinoplasties. One surgeon uses cocaine as the vasoconstrictor agent of choice in
his daily practice, whilst adrenaline is the preferred option for the other. Both
practitioners participate in all surgeries, one of them as main surgeon and the other as
assistant alternatively until the study is concluded.
Vasoconstrictor effect of cocaine and adrenaline will be assessed by quantitative and
qualitative evaluation. Blood loss is quantified by measuring blood aspiration during surgery
and gauze weighing. Aspiration is collected in a graduated bottle; at the end of surgery
fourty cc of saline is flushed through the suction system. Difference of ribbon gauze weights
before and after the procedure is also measured. Adding the previous measurements gives an
estimate in blood loss. Qualitative analysis of vasoconstrictive effect is based on
evaluation of surgical field by each surgeon using a linear scale of 1 to 5 (1 poor, 5
excellent).
Systemic effect of vasoconstrictor drugs is assessed by heart rate (HR) and
systolic/diastolic blood pressure (SBP/DBP) variations during the procedure. Patients are
monitored with continuous electrocardiogram tracing and automated blood pressure. Once
cocaine or adrenaline packs are placed, measurements are taken every two and a half minutes
during the first ten minutes and thereafter every five minutes until the end of the
procedure.
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