Propofol and Perioperative Inflammation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01115179

Enrollment

Registered

2010-05-04

Start date

2005-03-31

Completion date

2005-12-31

Last updated

2010-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

propofol, inflammation, perioperative, lipids, Apolipoprotein A-I

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.

Interventions

DRUGpropofol

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)

DRUGIntralipid 10%

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)

DRUGSaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

30 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Apolipoprotein A-I level	24 hours after surgery

Secondary

Measure	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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026