Propofol and Perioperative Inflammation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Inflammation	Drug: propofol Drug: Intralipid 10% Drug: Saline	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title:	Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study

Resource links provided by NLM:

Drug Information available for: Propofol Liposyn II Liposyn III

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Apolipoprotein A-I level [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Interleukin-6 level [ Time Frame: 5 hours after surgery ] [ Designated as safety issue: No ]
C-reactive protein (CRP) level [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
Cortisol level [ Time Frame: 15 min after induction of anesthesia ] [ Designated as safety issue: No ]

Enrollment:	79
Study Start Date:	March 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Propofol Propofol anesthesia	Drug: propofol 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) Other Name: Propofol, Ansiven
Active Comparator: Control Anesthesia with isoflurane alone	Drug: Saline Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%) Other Name: NaCl 0.9%
Active Comparator: Solvent Anesthesia with isoflurane together with the solvent of propofol (intralipid)	Drug: Intralipid 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) Other Name: Intralipid

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115179

Locations

Switzerland
Service of Anesthesiology; Geneva University Hospital
Geneva, Switzerland, 1211

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Study Chair:	Bara Ricou, Prof.	Service of Intensive Care, Geneva University Hospital
Principal Investigator:	Oliver Bandschapp, M.D.	Service of Intensive Care, Geneva University Hospital

More Information

Publications:

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.

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.

Responsible Party:	Bara Ricou, Service of Intensive Care, Department APSI, Geneva University Hospital
ClinicalTrials.gov Identifier:	NCT01115179 History of Changes
Other Study ID Numbers:	APSIC 04-014, CER: 04-189
Study First Received:	April 27, 2010
Last Updated:	May 17, 2010
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

propofol
inflammation
perioperative
lipids
Apolipoprotein A-I

Additional relevant MeSH terms:

Inflammation
Pathologic Processes
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 22, 2013