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Inflammation After One Lung Ventilation

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ClinicalTrials.gov Identifier: NCT02188407
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Iztok Potocnik, University Medical Centre Ljubljana

Brief 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.


Condition or disease Intervention/treatment Phase
Inflammation Drug: Sevoflurane Drug: Propofol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sevoflurane
Sevoflurane group (S group)- The group anaesthesied with sevoflurane
Drug: Sevoflurane
MAC 3-5 V% during surgery
Other Name: Sevorane

Active Comparator: Propofol
Propofol 4-6 mg/kg/h iv
Drug: Propofol
Propofol group (P group)- The group anaesthesied with propofol




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. CRP [ Time Frame: 24 hours after surgery ]
    CRP blood level 24 hours after surgery

  4. Oxygenation index [ Time Frame: 6h after surgery ]
    pO2/FiO2

  5. Lung infiltration [ Time Frame: 6h after surgery ]
    X-ray of the lung- clear lungs, partly infiltrated lungs, totally infiltrated lungs


Other Outcome Measures:
  1. Postoperative adverse events [ Time Frame: 24h after surgery ]
    Prolonged antibiotics Pneumonia Reintubation SIRS ARDS Sepsis Death Acute Renal Failure Pooperative nausea and vomiting



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188407


Locations
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Slovenia
UMCLjubljana, CD of Anaesthesiology and Intensive Therapy
Ljubljana, Slovenia, 1230
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Iztok Potocnik, MD, MSC University Medical Centre Ljubljana
Study Chair: Vesna Novak Jankovic, MD, PROF University Medical Centre Ljubljana
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iztok Potocnik, MD, MSC, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02188407    
Other Study ID Numbers: UKC-TOR-1
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Keywords provided by Iztok Potocnik, University Medical Centre Ljubljana:
thoracotomy
one-lung ventilation (OLV)
total intravenous anaesthesia (TIVA)
volatile induced and maintained anaesthesia (VIMA)
cytokines
interleukine (IL)
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation