Propofol and Perioperative Inflammation

University Hospitals (UH)

Status and phase: Completed; Phase 4

Conditions: Inflammation

Treatments: Drug: Saline; Drug: propofol; Drug: Intralipid 10%

Study type: Interventional

Funder types: Other

Identifiers

NCT01115179

APSIC 04-014

CER: 04-189 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

79 participants in 3 patient groups

Propofol

Active Comparator group

Description:

Propofol anesthesia

Treatment:

Drug: propofol

Control

Active Comparator group

Description:

Anesthesia with isoflurane alone

Treatment:

Drug: Saline

Solvent

Active Comparator group

Description:

Anesthesia with isoflurane together with the solvent of propofol (intralipid)

Treatment:

Drug: Intralipid 10%