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Completed

NCT Number: NCT01115179

Propofol and Perioperative Inflammation

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.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Service of Anesthesiology; Geneva University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Propofol

Drug

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 names: Propofol, Ansiven

Intralipid 10%

Drug

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 names: Intralipid

Saline

Drug

Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%)

Other names: NaCl 0.9%

Primary outcomes

  1. Apolipoprotein A-I level

    Time frame: 24 hours after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
May 4, 2010
Registry last updated
May 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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