Propofol and Perioperative Inflammation

Phase 4

Completed

• Conditions: Inflammation
• Interventions: Drug: Saline; Drug: Intralipid 10%; Drug: propofol

• Registration Number: NCT01115179
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2010-04
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 79

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	Anesthesia with isoflurane alone
Solvent	Intralipid 10%	Anesthesia with isoflurane together with the solvent of propofol (intralipid)
Propofol	propofol	Propofol anesthesia

Primary Outcome Measures

Name	Time	Method
Apolipoprotein A-I level	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Interleukin-6 level	5 hours after surgery
C-reactive protein (CRP) level	24 hours after surgery
Cortisol level	15 min after induction of anesthesia

Trial Locations

Locations (1)

Service of Anesthesiology; Geneva University Hospital; 🇨🇭 Geneva, Switzerland