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

April 20, 2015 updated by: Clínica Fernández
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Clinica Fernández

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy females elegible for cosmetic rhinoplasty.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding in rhinoplasty procedures.
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Time Frame
Blood pressure and heart rate variations during rhinoplasty.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica Fernández

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (ESTIMATE)

March 6, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CF-00115-vs

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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