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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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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12612000245897 |
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Date of registration:
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28/02/2012 |
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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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Influence of glucocorticoids on sugammadex action
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Scientific title:
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A randomized parallel group study of glucocorticoids influence on sugammadex efficacy in patients anesthetized for elective surgery |
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Date of first enrolment:
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02/02/2012 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12612000245897.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Katja Rezonja
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Address:
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Pribinova 7, 1000 Ljubljana
Slovenia |
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Telephone:
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+386 31 479 544 |
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Email:
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katja.rezonja@gmail.com |
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Affiliation:
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Name:
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Katja Rezonja
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Address:
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Pribinova 7, 1000 Ljubljana
Slovenia |
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Telephone:
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+386 31 479 544 |
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Email:
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katja.rezonja@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients anesthetized for elective surgery for which they need to be intubated and fully relaxed throughout the procedure, ASA I-III.
Exclusion criteria: Lack of consent, patients with neuromuscular disease, with anticipated difficult intubation, kidney failure, personal or family history of malignant hyperthermia, allergy to any anesthetics used, pregnant or nursing women, women taking oral contraceptives, patients receiving drugs that could interfere with sugammadex.
Age minimum:
18 Years
Age maximum:
100 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Anaesthetics
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Residual neuromuscular blockade;
Residual neuromuscular blockade
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Intervention(s)
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We will clinically evaluate (using TOF values) residual neuromuscular blockade after reversal with sugammadex in patients intraoperatively receiving glucocorticoids (dexamethasone 0,15 mg/kg i.v. at the end of the operation) for PONV prevention in comparison to individuals, receiving standard treatment (granisetron 1 mg i.v. after induction) - control group. Concurrently we will withdraw a blood sample before and after application of sugammadex to measure rocuronium and dexamethasone (in observation group) blood level.
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Primary Outcome(s)
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We will measure acceleromyographic response of ulnar nerve stimulation on m. pollicis brevis through TOF (train-of- four) value.[Measurements will start at the end of operation, just before i.v. application of sugammadex and will continue in 15 second intervals until full recovery of muscle strength (TOF value > 90%).]
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Secondary Outcome(s)
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Blood dexamethason concentration (in observational group).[Before sugammadex application and after full reversal of neuromuscular block according to TOF.]
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Blood rocuronium concentration (in both groups).[Before sugammadex application and after full reversal of neuromuscular block according to TOF.]
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Source(s) of Monetary Support
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University Medical Center Ljubljana
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Ethics review
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Status: Approved
Approval date:
Contact:
National Medical Ethics Committee of the Republic of Slovenia
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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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