Inflammation After One Lung Ventilation
|ClinicalTrials.gov Identifier: NCT02188407|
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Inflammation||Drug: Sevoflurane Drug: Propofol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 1 Study of Antiinflammatory Effect of Sevoflurane in Open Lung Surgery With One-Lung Ventilation|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||January 2014|
Sevoflurane group (S group)- The group anaesthesied with sevoflurane
MAC 3-5 V% during surgery
Other Name: Sevorane
Active Comparator: Propofol
Propofol 4-6 mg/kg/h iv
Propofol group (P group)- The group anaesthesied with propofol
- IL 6 [ Time Frame: intraoperatively and 6 hours after surgery ]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
- IL8 [ Time Frame: intraoperatively , 6 hours after surgery ]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
- IL10 [ Time Frame: intraoperatively , 6 hours after surgery ]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
- CRP [ Time Frame: 24 hours after surgery ]CRP blood level 24 hours after surgery
- Oxygenation index [ Time Frame: 6h after surgery ]pO2/FiO2
- Lung infiltration [ Time Frame: 6h after surgery ]X-ray of the lung- clear lungs, partly infiltrated lungs, totally infiltrated lungs
- Postoperative adverse events [ Time Frame: 24h after surgery ]Prolonged antibiotics Pneumonia Reintubation SIRS ARDS Sepsis Death Acute Renal Failure Pooperative nausea and vomiting
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188407
|UMCLjubljana, CD of Anaesthesiology and Intensive Therapy|
|Ljubljana, Slovenia, 1230|
|Principal Investigator:||Iztok Potocnik, MD, MSC||University Medical Centre Ljubljana|
|Study Chair:||Vesna Novak Jankovic, MD, PROF||University Medical Centre Ljubljana|