Vascular SurgeryPhase 4PHARNCT03215446
Evaluate the Muscle Protection Effect of Sevoflurane Sedation in Vascular Surgery
A Phase 4 study testing maintenance of anaesthesia with propofol and maintenance of anaesthesia with sevoflurane in people with Vascular Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class effect, and Sevoflurane is the most widely used today. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Surgery
- What is being tested?
- maintenance of anaesthesia with propofol and maintenance of anaesthesia with sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2016to 19 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons who have provided written consent
- patients over 18 years of age
- patients undergoing scheduled vascular surgery with high clamping for:
- Abdominal aortic aneurysm
- suprapopliteal vascular bypass (aorto-bi-femoral, femoral trifurcation, ilio-femoral or femoro-femoral, femoro-popliteal).
Who cannot join
- persons without health insurance cover
- patients younger than 18 years of age, pregnant or breast-feeding women and adults under guardianship
- patients with epilepsy
- emergency surgery
- patient presenting a contra-indication for Sevoflurane: hypersensitivity to sevoflurane or to other halogenated anaesthetic agents, myopathy, hyper-eosinophilia, immunoallergic hepatitis, known or suspected genetic predisposition to malignant hyperthermia
- patients presenting a contra-indication to the use of Propofol: known hypersensitivity to propofol or to one of the constituents of the product, allergy to peanuts or soja
Show all 12Show fewer
- Patients presenting a contra-indication for sufentanil: hypersensitivity to sufentanil or to opioids
- Association with opioid agonists-antagonists or partial opioid antagonists
- patients presenting a CI for the use of Cisatracurium: history of allergy or hypersensitivity to cisatracurium or atracurium
- patients presenting cardiac, respiratory, renal or kidney failure, hypovolemia, poor general health
- Patients with a risl of prolongation of the QT interval
- Patients with end-stage renal failure - requiring dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Total (Pre and Post) Conditioning on Rhabdomyolysis of Sedation With Sevoflurane Versus Propofol in Vascular Surgery With Clamping
Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class effect, and Sevoflurane is the most widely used today.
In humans, the protective effects of halogenated agents have principally been studied in heart surgery and have shown encouraging clinical results. It seems that HAA induce both pre-conditioning of the myocardium (early and late) and post conditioning.
Given these protective effects of HAA, in 2007, the American Heart Association (AHA) recommended the use of HAA for anaesthesia maintenance in non-cardiac surgery in patients with a high cardio-vascular risk. The aim of this study is to show a decrease in rhabdomyolysis and tissue distress (kidneys, myocardium and liver), thanks to Sevoflurane anaesthesia, in the post-operative period following vascular surgery with clamping
- Conditions
- Vascular Surgery
- Being tested
- maintenance of anaesthesia with propofol, maintenance of anaesthesia with sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance of anaesthesia with propofolDrug
maintenance of anaesthesia with sevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | Not described Receives: Drug: maintenance of anaesthesia with propofol |
| sevoflurane | Experimental | Not described Receives: Drug: maintenance of anaesthesia with sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline Creatine PhosphoKinase
Measured: up to 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start13 Jun 2016
- Primary completion29 May 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215446
- Sponsor's protocol ID
- STEINBERG-GIRARD 2015
- Acronym
- PHAR
- Status last verified
- Jan 2021
- First submitted
- 26 Jun 2017
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Total (Pre and Post) Conditioning on Rhabdomyolysis of Sedation With Sevoflurane Versus Propofol in Vascular Surgery With Clamping
- ClinicalTrials.gov ID
- NCT03215446
- Acronym / sponsor ID
- PHAR / STEINBERG-GIRARD 2015
- Conditions
- Vascular Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- 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.
Halogenated anaesthetic agents (HAA) may induce protective processes by pre-conditioning the myocardium. All of the literature shows that HAA induce pre-conditioning, thanks to a class effect, and Sevoflurane is the most widely used today.
In humans, the protective effects of halogenated agents have principally been studied in heart surgery and have shown encouraging clinical results. It seems that HAA induce both pre-conditioning of the myocardium (early and late) and post conditioning.
Given these protective effects of HAA, in 2007, the American Heart Association (AHA) recommended the use of HAA for anaesthesia maintenance in non-cardiac surgery in patients with a high cardio-vascular risk. The aim of this study is to show a decrease in rhabdomyolysis and tissue distress (kidneys, myocardium and liver), thanks to Sevoflurane anaesthesia, in the post-operative period following vascular surgery with clamping
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: maintenance of anaesthesia with propofol |
| sevoflurane | Experimental | Drug: maintenance of anaesthesia with sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- persons who have provided written consent
- patients over 18 years of age
- patients undergoing scheduled vascular surgery with high clamping for:
- Abdominal aortic aneurysm
- suprapopliteal vascular bypass (aorto-bi-femoral, femoral trifurcation, ilio-femoral or femoro-femoral, femoro-popliteal).
Key exclusion criteria (12 listed)
- persons without health insurance cover
- patients younger than 18 years of age, pregnant or breast-feeding women and adults under guardianship
- patients with epilepsy
- emergency surgery
- patient presenting a contra-indication for Sevoflurane: hypersensitivity to sevoflurane or to other halogenated anaesthetic agents, myopathy, hyper-eosinophilia, immunoallergic hepatitis, known or suspected genetic predisposition to malignant hyperthermia
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 |
|---|---|---|
| maintenance of anaesthesia with propofol | Drug | propofol |
| maintenance of anaesthesia with sevoflurane | Drug | sevoflurane |
Primary outcome
change from baseline Creatine PhosphoKinase
Time frame: up to 24 hours post surgery
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 25 Jan 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 maintenance of anaesthesia with propofol and maintenance of anaesthesia with sevoflurane in people with Vascular Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 inclusion and 12 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 25 Jan 2021. 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 France. 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?
change from baseline Creatine PhosphoKinase (time frame: up to 24 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2021.