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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02155517 |
Date of registration:
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19/05/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Clinical Effect of Two Pharmacokinetics Model of Propofol
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Scientific title:
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Phase 4: CLINICAL EVALUATION OF TWO PHARMACOKINETICS MODELS OF PROPOFOL IN HEALTHY PEOPLE |
Date of first enrolment:
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May 2014 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02155517 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
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Phase:
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Phase 4
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Countries of recruitment
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Venezuela
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Contacts
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Name:
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Carlos R Ramirez, Dr |
Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA physical status I
- Aged 18-60 years
- Patients with Body mass Index < 30.
Exclusion Criteria:
- Patients with Body mass Index > 30.
- Patients presenting psychiatric or neurological disorders , endocrine-metabolical
problems, respiratory and cardiac diseases, or with allergies problems.
- Patients who are pregnant or breastfeeding.
- Patients treated with psychotropic drugs, including alcohol, in the 48 hours prior.
- Patients with previous history of anesthetics complications
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Evaluation of propofol effect
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Primary Outcome(s)
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Sedation Levels
[Time Frame: During propofol infusion period]
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Secondary Outcome(s)
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Hemodynamics values
[Time Frame: During propofol infusion period]
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Bispectral index values
[Time Frame: During a propofol infusion period]
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Secondary ID(s)
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019CBCEA032013
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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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