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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01282203 |
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Date of registration:
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21/01/2011 |
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Primary sponsor: |
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Public title:
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Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice
SEVOPROTECTION |
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Scientific title:
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Evaluation of VIMA With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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1122 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01282203 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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Kazakhstan
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Contacts
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Name:
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Irina Magdik, MD, PhD, MBA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott Laboratories S.A., Ukraine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Any patients needed general anesthesia for planned or urgent surgery for whom
Sevorane is used for induction and maintenance anesthesia by the choice of
anesthesiologist
Exclusion Criteria:
- known sensitivity to sevoflurane or other anesthetic containing halogen
- known or suspected genetic susceptibility to malignant hyperthermia
- receiving regional anesthetic techniques
- receiving intravenous anesthesia
- a history of unexplained moderate/severe hepatic dysfunction with jaundice, fever,
and/or eosinophilia in association with halogenated anesthetics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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General Surgery
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Intervention(s)
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Drug: sevoflurane
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Primary Outcome(s)
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doctors' satisfaction with using Sevorane for induction and maintenance anesthesia
[Time Frame: Day 1]
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patients' satisfaction and general impressions of using Sevorane anesthesia
[Time Frame: Day 1]
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time of induction
[Time Frame: Day 1]
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time to awaking
[Time Frame: Day 1]
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time to extubation
[Time Frame: Day 1]
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Secondary Outcome(s)
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cardiac troponin (Troponin T/I (ng/mL)) (if available)
[Time Frame: Day 1]
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creatine kinase myocardial isoenzyme (CFK-MB (units/L)) (if available)
[Time Frame: within 24h after anesthesia]
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diastolic arterial pressure
[Time Frame: Day 1]
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electrocardiogram data (if available)
[Time Frame: Day 1]
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heart rate (beat per minute)
[Time Frame: Day 1]
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length of clinical experience of general anesthesia
[Time Frame: Day 1]
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length of clinical experience with modern inhalation agents
[Time Frame: Day 1]
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mean arterial pressure
[Time Frame: Day 1]
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systolic arterial pressure
[Time Frame: Day 1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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