Clinical trial NCT01115179: Propofol and Perioperative Inflammation
Official title: Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Keywords: propofol
inflammation
perioperative
lipids
Apolipoprotein A-I
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 79
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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)

Primary outcomes:
measure: Apolipoprotein A-I level
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Interleukin-6 level
timeFrame: 5 hours after surgery
measure: C-reactive protein (CRP) level
timeFrame: 24 hours after surgery
measure: Cortisol level
timeFrame: 15 min after induction of anesthesia
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Service of Anesthesiology; Geneva University Hospital
Study officials:
affiliation: Service of Intensive Care, Geneva University Hospital
name: Bara Ricou, Prof.
role: STUDY_CHAIR
affiliation: Service of Intensive Care, Geneva University Hospital
name: Oliver Bandschapp, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chenaud C, Merlani PG, Roux-Lombard P, Burger D, Harbarth S, Luyasu S, Graf JD, Dayer JM, Ricou B. Low apolipoprotein A-I level at intensive care unit admission and systemic inflammatory response syndrome exacerbation. Crit Care Med. 2004 Mar;32(3):632-7. doi: 10.1097/01.ccm.0000114820.47460.0a.
citation: Hyka N, Dayer JM, Modoux C, Kohno T, Edwards CK 3rd, Roux-Lombard P, Burger D. Apolipoprotein A-I inhibits the production of interleukin-1beta and tumor necrosis factor-alpha by blocking contact-mediated activation of monocytes by T lymphocytes. Blood. 2001 Apr 15;97(8):2381-9. doi: 10.1182/blood.v97.8.2381.