Inflammation After One Lung Ventilation

NCT02188407 | Completed Phase 1 DMC

• 1 other identifier: UKC-TOR-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

thoracotomy; one-lung ventilation (OLV); total intravenous anaesthesia (TIVA); volatile induced and maintained anaesthesia (VIMA); cytokines; interleukine (IL)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• IL8

  intraoperatively , 6 hours after surgery

• IL10

  intraoperatively , 6 hours after surgery

• CRP

  24 hours after surgery

• Oxygenation index

  6h after surgery

• Lung infiltration

  6h after surgery

Other Outcomes (1)

• Postoperative adverse events

  24h after surgery

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Sevoflurane group (S group)- The group anaesthesied with sevoflurane

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

Propofol 4-6 mg/kg/h iv

Drug: Propofol

Interventions

Sevoflurane DRUG

MAC 3-5 V% during surgery

Also known as: Sevorane

Sevoflurane

Propofol DRUG

Propofol group (P group)- The group anaesthesied with propofol

Propofol

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20-70 years
• American Society of Anaesthesiologists (ASA) physical status I-III
• elective open lobectomy with OLV

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMCLjubljana, CD of Anaesthesiology and Intensive Therapy

Ljubljana, 1230, Slovenia

Location

Related Publications (4)

• 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. Anesthesiology. 2009 Jun;110(6):1316-26. doi: 10.1097/ALN.0b013e3181a10731.

  PMID: 19417610 RESULT

• 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: 10.1097/ALN.0b013e318214b9de.

  PMID: 21399490 RESULT

• Schilling T, Kozian A, Kretzschmar M, Huth C, Welte T, Buhling 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. doi: 10.1093/bja/aem184. Epub 2007 Jul 9.

  PMID: 17621602 RESULT

• Potocnik I, Novak Jankovic V, Sostaric M, Jerin A, Stupnik T, Skitek M, Markovic-Bozic J, Klokocovnik T. Antiinflammatory effect of sevoflurane in open lung surgery with one-lung ventilation. Croat Med J. 2014 Dec;55(6):628-37. doi: 10.3325/cmj.2014.55.628.

  PMID: 25559834 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Iztok Potocnik, MD, MSC

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

• Vesna Novak Jankovic, MD, PROF

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSC

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

SL (1)