InflammationPhase 4NCT01115179
Propofol and Perioperative Inflammation
A Phase 4 study testing propofol, Intralipid 10% and Saline in people with Inflammation, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- propofol, Intralipid 10% and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2005to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I or II
- scheduled for uni- or bilateral elective laparoscopic totally extraperitoneal hernia repair
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service of Anesthesiology; Geneva University Hospital
Geneva, Canton of Geneva, 1211
About this study
Official title: Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study
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
- Being tested
- propofol, Intralipid 10%, Saline
- Keywords
- propofol, inflammation, perioperative, lipids, Apolipoprotein A-I
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Propofol, Ansiven
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%Drug
Also called Intralipid
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)
SalineDrug
Also called NaCl 0.9%
Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%)
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol anesthesia Receives: Drug: propofol |
| Control | Active comparator | Anesthesia with isoflurane alone Receives: Drug: Saline |
| Solvent | Active comparator | Anesthesia with isoflurane together with the solvent of propofol (intralipid) Receives: Drug: Intralipid 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apolipoprotein A-I level
Measured: 24 hours after surgery
Secondary outcomes (3)
Interleukin-6 level
Measured: 5 hours after surgery
C-reactive protein (CRP) level
Measured: 24 hours after surgery
Cortisol level
Measured: 15 min after induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Bara Ricou, Prof., Study chair, Service of Intensive Care, Geneva University HospitalOliver Bandschapp, M.D., Principal investigator, Service of Intensive Care, Geneva University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115179
- Sponsor's protocol ID
- APSIC 04-014
- Other IDs
- CER: 04-189
- Status last verified
- Apr 2010
- First submitted
- 27 Apr 2010
- Last updated
- 19 May 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/01.ccm.0000114820.47460.0a.
PubMed 15090939Hyka 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.
PubMed 11290601
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT01115179
- Acronym / sponsor ID
- APSIC 04-014
- Conditions
- Inflammation
- Keywords
- propofol, inflammation, perioperative, lipids, Apolipoprotein A-I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofolPropofol anesthesia |
| Control | Active comparator | Drug: SalineAnesthesia with isoflurane alone |
| Solvent | Active comparator | Drug: Intralipid 10%Anesthesia with isoflurane together with the solvent of propofol (intralipid) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) I or II
- scheduled for uni- or bilateral elective laparoscopic totally extraperitoneal hernia repair
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: Propofol, AnsivenInduction 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) | Drug | Propofol |
| Intralipid 10%Also: IntralipidInduction 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) | Drug | Solvent |
| SalineAlso: NaCl 0.9%Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%) | Drug | Control |
Primary outcome
Apolipoprotein A-I level
Time frame: 24 hours after surgery
3 secondary outcomes
Interleukin-6 level
Time frame: 5 hours after surgery
C-reactive protein (CRP) level
Time frame: 24 hours after surgery
Cortisol level
Time frame: 15 min after induction of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2010.
- Background: PubMed 15090939Chenaud 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.
- Background: PubMed 11290601Hyka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bara Ricou, Prof. study chair
Service of Intensive Care, Geneva University Hospital
Oliver Bandschapp, M.D. principal investigator
Service of Intensive Care, Geneva University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol, Intralipid 10% and Saline in people with Inflammation, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apolipoprotein A-I level (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01115179, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2010.