Propofol and Perioperative Inflammation

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammation

Intervention / Treatment
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* Drug: propofol
* Drug: Intralipid 10%
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>Propofol anesthesia | Drug: propofol<br>* 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)<br>* Other names: Propofol, Ansiven;|
| Active Comparator: Control<br>Anesthesia with isoflurane alone | Drug: Saline<br>* Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%)<br>* Other names: NaCl 0.9%;|
| Active Comparator: Solvent<br>Anesthesia with isoflurane together with the solvent of propofol (intralipid) | Drug: Intralipid 10%<br>* 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)<br>* Other names: Intralipid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apolipoprotein A-I level |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 level |  | 5 hours after surgery | 
| C-reactive protein (CRP) level |  | 24 hours after surgery | 
| Cortisol level |  | 15 min after induction of anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, inflammation, perioperative, lipids, Apolipoprotein A-I