Propofol and Perioperative Inflammation

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Geneva
• Treatments: Anesthetics; Isoflurane; Propofol; Soybean oil, phospholipid emulsion

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)