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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 May 2015 |
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Main ID: |
NCT02381041 |
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Date of registration:
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02/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparative Evaluation of Cocaine and Adrenaline as Topical Vasonconstrictor Agents in Cosmetic Rhinoplasty
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Scientific title:
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Comparative Evaluation of Cocaine and Adrenaline as Topical Vasonconstrictor Agents in Cosmetic Rhinoplasty |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02381041 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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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).
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Rhinoplasty
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MeSh E02.218.755
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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.]
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Secondary ID(s)
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CF-00115-vs
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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