Propofol and Perioperative Inflammation

NCT01115179 | Completed Phase 4

• 2 other identifiers: APSIC 04-014CER: 04-189
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Apolipoprotein A-I level

  24 hours after surgery

Secondary Outcomes (3)

• Interleukin-6 level

  5 hours after surgery

• C-reactive protein (CRP) level

  24 hours after surgery

• Cortisol level

  15 min after induction of anesthesia

Study Arms (3)

Propofol

ACTIVE COMPARATOR

Propofol anesthesia

Drug: propofol

Control

ACTIVE COMPARATOR

Anesthesia with isoflurane alone

Drug: Saline

Solvent

ACTIVE COMPARATOR

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

Drug: Intralipid 10%

Interventions

propofol DRUG

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)

Also known as: Propofol, Ansiven

Propofol

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)

Also known as: Intralipid

Solvent

Saline DRUG

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

Also known as: NaCl 0.9%

Control

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) I or II
• scheduled for uni- or bilateral elective laparoscopic totally extraperitoneal hernia repair

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Service of Anesthesiology; Geneva University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 15090939 BACKGROUND

• 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.

  PMID: 11290601 BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Propofol; soybean oil, phospholipid emulsion; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bara Ricou, Prof.

  Service of Intensive Care, Geneva University Hospital

  STUDY CHAIR

• Oliver Bandschapp, M.D.

  Service of Intensive Care, Geneva University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 4, 2010
• Study Start: March 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 19, 2010

Record last verified: 2010-04

Locations

CH (1)