Comparative Evaluation of Cocaine and Adrenaline as Topical Vasonconstrictor Agents in Cosmetic Rhinoplasty

Rhinoplasty Clinical Trial

Official title:

Comparative Evaluation of Cocaine and Adrenaline as Topical Vasonconstrictor Agents in Cosmetic Rhinoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381041
• Other study ID #: CF-00115-vs
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: April 20, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: Clínica Fernández
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Provide written consent authorization.

• Preoperatively assessed as ASA l or ll.

Exclusion Criteria:

• Known allergy to any ester based anesthetics.

• Pregnant or nursing mother.

• Any alteration of nasal mucouse that might interfere either with absorption of topical vasoconstrictor agents or with the normal wound healing process.

• Patient has used acetylsalicylic acid or NSAID 5 days prior to surgery including:

ibuprofen, diclofenac, naproxen, diclofenac, indometacin, tolmetin.

• Has a known personal or family history of pheocromocytoma or adrenal tumor.

• The patient uses or has a prescribed need for stimulant drugs (amphetamines, ephedrine, norephedrine or pseudoephedrine).

Related Conditions & MeSH terms

• MeSh E02.218.755
• Rhinoplasty

Locations

Country	Name	City	State
Spain	Clinica Fernández	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Clínica Fernández

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding in rhinoplasty procedures.		Primary outcome measures will be assessed during the surgical procedure, from the moment the vasoconstrictive agents are applied. This time period is an average of one hour.
Secondary	Blood pressure and heart rate variations during rhinoplasty.		Secondary outcome measures will be assessed during the surgical procedure, from the moment the vasoconstrictive agents are applied. This time period is an average of one hour.