Propofol and Perioperative Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Propofol

Propofol anesthesia

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type 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)

Control

Anesthesia with isoflurane alone

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

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

Solvent

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

Group Type ACTIVE_COMPARATOR

Intralipid 10%

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Propofol, Ansiven Intralipid NaCl 0.9%

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes