Propofol and Perioperative Inflammation

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115179
• Other study ID #: APSIC 04-014
• Secondary ID: CER: 04-189
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2010
• Last updated: May 17, 2010
• Start date: March 2005
• Est. completion date: December 2005

Study information

• Verified date: April 2010
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Inflammation

Intervention

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

Locations

Country	Name	City	State
Switzerland	Service of Anesthesiology; Geneva University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apolipoprotein A-I level		24 hours after surgery	No
Secondary	Interleukin-6 level		5 hours after surgery	No
Secondary	C-reactive protein (CRP) level		24 hours after surgery	No
Secondary	Cortisol level		15 min after induction of anesthesia	No