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Propofol and Perioperative Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammation Drug: propofol Drug: Intralipid 10% Drug: Saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study
Study Start Date : March 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Propofol
Propofol anesthesia
 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
Active Comparator: Control
Anesthesia with isoflurane alone
 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%
Active Comparator: Solvent
Anesthesia with isoflurane together with the solvent of propofol (intralipid)
 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


Outcome Measures
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Primary Outcome Measures :
  1. Apolipoprotein A-I level [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. Interleukin-6 level [ Time Frame: 5 hours after surgery ]
  2. C-reactive protein (CRP) level [ Time Frame: 24 hours after surgery ]
  3. Cortisol level [ Time Frame: 15 min after induction of anesthesia ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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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): NCT01115179


Locations
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Switzerland
Service of Anesthesiology; Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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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
More Information
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Publications:

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Responsible Party: Bara Ricou, Service of Intensive Care, Department APSI, Geneva University Hospital
ClinicalTrials.gov Identifier: NCT01115179    
Other Study ID Numbers: APSIC 04-014
CER: 04-189 ( Other Identifier: Ethics Comission )
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: May 19, 2010
Last Verified: April 2010
Keywords provided by University Hospital, Geneva:
propofol
inflammation
perioperative
lipids
Apolipoprotein A-I
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Propofol
Soybean oil, phospholipid emulsion
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions