Propofol and Perioperative Inflammation

University Hospital, Geneva79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Inflammation

Interventions

propofolDRUG

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)

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)

SalineDRUG

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

Eligibility

Sex: MALEMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Service of Anesthesiology; Geneva University Hospital

Geneva, Canton of Geneva, Switzerland

Outcomes

Primary Outcomes

Apolipoprotein A-I level

Time frame: 24 hours after surgery

Secondary Outcomes

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

Data from ClinicalTrials.gov

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