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Propofol and Perioperative Inflammation

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ClinicalTrials.gov Identifier: NCT01115179
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : May 19, 2010
Sponsor:
Information provided by:
University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE April 27, 2010
First Posted Date  ICMJE May 4, 2010
Last Update Posted Date May 19, 2010
Study Start Date  ICMJE March 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
Apolipoprotein A-I level [ Time Frame: 24 hours after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
  • Interleukin-6 level [ Time Frame: 5 hours after surgery ]
  • C-reactive protein (CRP) level [ Time Frame: 24 hours after surgery ]
  • Cortisol level [ Time Frame: 15 min after induction of anesthesia ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Propofol and Perioperative Inflammation
Official Title  ICMJE Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study
Brief Summary The inflammatory properties of propofol are still under debate. Apolipoprotein A-I (Apo A-I) is involved in the inflammatory process. This study was designed to determine whether and how propofol or its solvent modulate Apo A-I and the inflammatory response after surgical stress. The investigators study hypothesis was that propofol might modify the Apo A-I blood levels, and thus, modulate the postoperative inflammatory course.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Inflammation
Intervention  ICMJE
  • Drug: propofol
    Induction with propofol (1.5 to 2mg/kg) and maintenance of anesthesia with propofol 1% (target controlled infusion with concentration levels of 3-5 ug/ml)
    Other Name: Propofol, Ansiven
  • Drug: Intralipid 10%
    Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%) as well as the solvent of propofol 1% (Intralipid 10%; corresponding to a target-controlled infusion of propofol with concentration levels of 3-5ug/ml)
    Other Name: Intralipid
  • Drug: Saline
    Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%)
    Other Name: NaCl 0.9%
Study Arms  ICMJE
  • Active Comparator: Propofol
    Propofol anesthesia
    Intervention: Drug: propofol
  • Active Comparator: Control
    Anesthesia with isoflurane alone
    Intervention: Drug: Saline
  • Active Comparator: Solvent
    Anesthesia with isoflurane together with the solvent of propofol (intralipid)
    Intervention: Drug: Intralipid 10%
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2010)
79
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I or II
  • scheduled for uni- or bilateral elective laparoscopic totally extraperitoneal hernia repair

Exclusion Criteria:

  • Body mass index (BMI) < 18.5 or > 39.9kg/m2
  • treatments with steroids (>5mg/d prednisone equivalent, for the last 30 days)
  • with opioids/non-steroidal anti-inflammatory drugs (NSAIDs) for chronic pain during the last 30 days
  • immunosuppression (AIDS, neutropenia <1000 cells/ml, transplant surgery, chemotherapy)
  • known lipid disorder (triglycerides >2.00mmol/l, low-density lipoprotein (LDL)-cholesterol >2.50mmol/l or high-density lipoprotein (HDL)-cholesterol < 1.00mmol/l)
  • hypolipemic treatment before admission
  • thyroid metabolism disorder (thyroid-stimulating hormone >6.0 mUI/l or <0.4mUI/l)
  • renal insufficiency (creatinine >106umol/l)
  • liver disorder (bilirubin >20umol/l, thromboplastin time <60%)
  • insulin dependant diabetes
  • parenteral nutrition or after any lipid-containing medication (propofol, intralipid, etomidate) during the last 30 days
  • antihypertensive medication with diltiazem or other calcium channel blockers
  • known chronic alcoholism (men: >65-75 ml alcohol/day)
  • multidrug abuse (cocaine, heroin, methadone, or other narcotics, sedatives or stimulants)
  • mental illness
  • known allergy to propofol after randomization:
  • change of surgical strategy
  • protocol violation
  • major bleeding (>0.5l)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01115179
Other Study ID Numbers  ICMJE APSIC 04-014
CER: 04-189 ( Other Identifier: Ethics Comission )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bara Ricou, Service of Intensive Care, Department APSI, Geneva University Hospital
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bara Ricou, Prof. Service of Intensive Care, Geneva University Hospital
Principal Investigator: Oliver Bandschapp, M.D. Service of Intensive Care, Geneva University Hospital
PRS Account University Hospital, Geneva
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP