Inflammation After One Lung Ventilation (NCT02188407) | Clinical Trial Compass
CompletedPhase 1
Inflammation After One Lung Ventilation
Slovenia40 participantsStarted 2008-07
Plain-language summary
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.
Who can participate
Age range20 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
IL 6
Timeframe: intraoperatively and 6 hours after surgery