Inflammation Clinical Trial
Official title:
Phase 1 Study of Antiinflammatory Effect of Sevoflurane in Open Lung Surgery With One-Lung Ventilation
Verified date | July 2014 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study was to prospectively investigate the influence of one-lung ventilation
(OLV) on the inflammatory response and to identify possible antiinflammatory effects of the
volatile anaesthetic sevoflurane.
Forty patients undergoing thoracic surgery with OLV were enrolled in this prospective,
randomised study. The patients were randomly allocated into two groups to receive either
propofol (Group P) or sevoflurane (Group S) for induction and maintenance of anaesthesia.
Inflammatory mediators (Interleukin 6 (IL6), Interleukin8 (IL8), Interleukin 10 (IL10), (C-
reactive protein)CRP) were measured intra- and postoperatively.
Six hours after surgery oxygenation index (PaO2/FiO2) was calculated and chest X ray was
taken and assessed.
The clinical outcome determinated by postoperative adverse events was assessed as the
secondary endpoint.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 2014 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Slovenia | UMCLjubljana, CD of Anaesthesiology and Intensive Therapy | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
De Conno E, Steurer MP, Wittlinger M, Zalunardo MP, Weder W, Schneiter D, Schimmer RC, Klaghofer R, Neff TA, Schmid ER, Spahn DR, Z'graggen BR, Urner M, Beck-Schimmer B. Anesthetic-induced improvement of the inflammatory response to one-lung ventilation. — View Citation
Schilling T, Kozian A, Kretzschmar M, Huth C, Welte T, Bühling F, Hedenstierna G, Hachenberg T. Effects of propofol and desflurane anaesthesia on the alveolar inflammatory response to one-lung ventilation. Br J Anaesth. 2007 Sep;99(3):368-75. Epub 2007 Ju — View Citation
Schilling T, Kozian A, Senturk M, Huth C, Reinhold A, Hedenstierna G, Hachenberg T. Effects of volatile and intravenous anesthesia on the alveolar and systemic inflammatory response in thoracic surgical patients. Anesthesiology. 2011 Jul;115(1):65-74. doi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Postoperative adverse events | Prolonged antibiotics Pneumonia Reintubation SIRS ARDS Sepsis Death Acute Renal Failure Pooperative nausea and vomiting | 24h after surgery | |
Primary | IL 6 | IL 6 blood level (ng/L) at the 1. Insertion of the retractor, 2. Begining of OLV 3. End of surgery, 4. Six hours after surgery | intraoperatively and 6 hours after surgery | |
Secondary | IL8 | IL 8 (mg/L) blood level at the 1. Insertion of the retractor, 2. Begining of OLV 3. End of surgery, 4. Six hours after surgery | intraoperatively , 6 hours after surgery | |
Secondary | IL10 | IL 10 blood level (ng/L) at the 1. Insertion of the retractor, 2. Begining of OLV 3. End of surgery, 4. Six hours after surgery | intraoperatively , 6 hours after surgery | |
Secondary | CRP | CRP blood level 24 hours after surgery | 24 hours after surgery | |
Secondary | Oxygenation index | pO2/FiO2 | 6h after surgery | |
Secondary | Lung infiltration | X-ray of the lung- clear lungs, partly infiltrated lungs, totally infiltrated lungs | 6h after surgery |
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