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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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19 February 2015 |
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Main ID: |
NCT02188407 |
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Date of registration:
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03/07/2014 |
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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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Inflammation After One Lung Ventilation
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Scientific title:
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Phase 1 Study of Antiinflammatory Effect of Sevoflurane in Open Lung Surgery With One-Lung Ventilation |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02188407 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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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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Iztok Potocnik, MD, MSC |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Ljubljana |
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Name:
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Vesna Novak Jankovic, MD, PROF |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Centre Ljubljana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged 20-70 years
- American Society of Anaesthesiologists (ASA) physical status I-III
- elective open lobectomy with OLV
Exclusion Criteria:
- history of drug hypersensitivity
- drug addiction
- treatment with psychotropic drugs
- severe psychiatric and central nerve system diseases
- persistent tobacco abuse, autoimmune system diseases
- diabetes mellitus
- cardiac failure (New York Heart Association class greater than 2)
- clinically relevant obstructive and restrictive lung diseases (vital capacity or
forced expiratory volume in 1s lover than 50% of the predicted values)
- pulmonary hypertension (mean pulmonary arterial pressure grater than 25 mmHg)
- pre-existing coagulation disorders
- history of treatment with immunosuppressant drugs in the 4 weeks before surgery
- Patient with evidence of pulmonary or systemic infections (C-reactive protein serum
concentration greater than 5 mg/L, leucocytosis greater than 10.0 bioparticles/L or
body temperature greater than 37 stC)
- perioperative blood derivatives, steroids or non-steroidal anti-inflammatory drug
(NSAID)
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inflammation
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Intervention(s)
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Drug: Propofol
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Drug: Sevoflurane
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Primary Outcome(s)
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IL 6
[Time Frame: intraoperatively and 6 hours after surgery]
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Secondary Outcome(s)
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Oxygenation index
[Time Frame: 6h after surgery]
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IL8
[Time Frame: intraoperatively , 6 hours after surgery]
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CRP
[Time Frame: 24 hours after surgery]
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IL10
[Time Frame: intraoperatively , 6 hours after surgery]
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Lung infiltration
[Time Frame: 6h after surgery]
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Secondary ID(s)
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UKC-TOR-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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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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