Endovascular Repair of Aortic AneurysmPhase 4NCT02107170
Effects of Anesthetics on Postoperative Cognitive Function of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
A Phase 4 study testing Sevoflurane, Propofol and Remifentanil in people with Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities, run by Tao Zhang at 1 site in China.
Trial summary
Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities are two kinds of common surgeries in the investigators' hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive function, are not clear. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Endovascular Repair of Aortic Aneurysm, Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities
- What is being tested?
- Sevoflurane, Propofol and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-100 years of age
- Patients presenting for Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities
Who cannot join
- Patients with pre-existing delirium
- Inablility to converse
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Comparison of Intravenous Anesthetics and Volatile Anesthetics on Postoperative Cognitive Dysfunction of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities are two kinds of common surgeries in the investigators' hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive function, are not clear. In this study investigators propose to measure postoperative cognitive function and other outcome of patients who are undergoing these two kinds of surgeries, and try to identify whether there is an association between different kinds of anesthetics and postoperative outcome. Investigators will also observe whether changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative delirium or cognitive change.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
sevoflurane-based general anesthesia
PropofolDrug
total intravenous anesthesia
RemifentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane & remifentanil | Experimental | sevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery. Receives: Drug: Sevoflurane; Drug: Remifentanil |
| propofol & remifentanil | Active comparator | propofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery. Receives: Drug: Propofol; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative cognitive dysfunction
Measured: 7 days after surgery
Secondary outcomes (2)
Number of patients with postoperative cognitive dysfunction
Measured: 3 months after surgery
Changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6 (a composite outcome measure)
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular Repair of Aortic AneurysmStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107170
- Sponsor's protocol ID
- VIAEV
- Status last verified
- Jun 2018
- First submitted
- 25 Mar 2014
- Last updated
- 12 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Anesthetics and Volatile Anesthetics on Postoperative Cognitive Dysfunction of Patients Undergoing Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities.
- ClinicalTrials.gov ID
- NCT02107170
- Acronym / sponsor ID
- VIAEV
- Conditions
- Endovascular Repair of Aortic Aneurysm, Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Apr 2014 (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.
Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities are two kinds of common surgeries in the investigators' hospital. The effects of anesthetic agents on postoperative outcome, especially cognitive function, are not clear. In this study investigators propose to measure postoperative cognitive function and other outcome of patients who are undergoing these two kinds of surgeries, and try to identify whether there is an association between different kinds of anesthetics and postoperative outcome. Investigators will also observe whether changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6, are associated with postoperative delirium or cognitive change.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane & remifentanil | Experimental | Drug: Sevoflurane, Drug: Remifentanilsevoflurane at 0.5 to 1.5 minimum alveolar concentrations plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery. |
| propofol & remifentanil | Active comparator | Drug: Propofol, Drug: Remifentanilpropofol (50 - 150 µg/kg/min) plus remifentanil (0.1 - 0.5 µg/kg/min) during the surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-100 years of age
- Patients presenting for Endovascular repair of aortic aneurysm and endovascular treatment of arteriosclerosis obliterans of lower extremities
Key exclusion criteria (2 listed)
- Patients with pre-existing delirium
- Inablility to converse
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 |
|---|---|---|
| Sevofluranesevoflurane-based general anesthesia | Drug | Sevoflurane & remifentanil |
| Propofoltotal intravenous anesthesia | Drug | propofol & remifentanil |
| Remifentanil | Drug | Sevoflurane & remifentanil, propofol & remifentanil |
Primary outcome
Number of patients with postoperative cognitive dysfunction
Time frame: 7 days after surgery
2 secondary outcomes
Number of patients with postoperative cognitive dysfunction
Time frame: 3 months after surgery
Changes in plasma levels of VEGF, TGF-1, TNF-α, IL-1β, and IL-6 (a composite outcome measure)
Time frame: 3 days after 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 12 Jun 2018.
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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 Sevoflurane, Propofol and Remifentanil in people with Endovascular Repair of Aortic Aneurysm and Endovascular Treatment of Arteriosclerosis Obliterans of Lower Extremities, run by Tao Zhang at 1 site in China.
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 2 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 12 Jun 2018. 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 China. 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?
Number of patients with postoperative cognitive dysfunction (time frame: 7 days after 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 12 Jun 2018.