Propofol and Perioperative Inflammation

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01115179
First received: April 27, 2010
Last updated: May 17, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Inflammation
Drug: propofol
Drug: Intralipid 10%
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Apolipoprotein A-I level [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interleukin-6 level [ Time Frame: 5 hours after surgery ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) level [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
  • Cortisol level [ Time Frame: 15 min after induction of anesthesia ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: March 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115179

Locations
Switzerland
Service of Anesthesiology; Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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

Publications:
Responsible Party: Bara Ricou, Service of Intensive Care, Department APSI, Geneva University Hospital
ClinicalTrials.gov Identifier: NCT01115179     History of Changes
Other Study ID Numbers: APSIC 04-014, CER: 04-189
Study First Received: April 27, 2010
Last Updated: May 17, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
propofol
inflammation
perioperative
lipids
Apolipoprotein A-I

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 20, 2014