EndarterectomyCEE-VIMANCT02771418
The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
A study testing Propofol, Sevoflurane and Elective carotid endarterectomy in people with Endarterectomy and Postoperative Cognitive Dysfunction, run by Northern State Medical University at 1 site in Russia.
Trial summary
Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and affect postoperative cognitive function. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Endarterectomy, Postoperative Cognitive Dysfunction
- What is being tested?
- Propofol, Sevoflurane and Elective carotid endarterectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2015to Jun 2016
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- Male gender
- Informed consent
- Symptomatic carotid stenosis > 75%
Who cannot join
- Contralateral carotid occlusion
- Known allergy to the one of the compared medications
Trial locations and contacts
1 site in 1 country.
Russia1 site
City hospital # 1 / Northern State Medical University,
Arkhangelsk, 163001
About this study
Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and affect postoperative cognitive function. The goal of this study was to assess the effects of anesthetics on perioperative cerebral oxygenation and cognitive functions.
Read the detailed description
Background: A transient deterioration of cerebral hemodynamics and oxygenation during CEE might involve both hemispheres of the brain and affects postoperative cognition. Despite some benefits of regional blocks, the majority of procedures of carotid endarterectomy (CEE) are performed under general anaesthesia. Surprisingly, the studies comparing the effects of sevoflurane and propofol on postoperative mental state in CEE are scarce and controversial. While propofol possesses some anti-inflammatory properties, volatile anesthetics can interfere with cerebral blood flow and reperfusion-ischaemia injury via the mechanism of pre- and postconditioning. The goal of this study is to assess the effects of the anesthetics on the perioperative cerebral oxygenation and cognitive functions in CEE.
Methods: The study and informed consent are approved by the Ethical Committee of the Northern State Medical University. Forty patients (males only) who are to undergo elective CEE will be included into a prospective study and randomised to two groups receiving either total intravenous anaesthesia (TIVA group, propofol + fentanyl) or the volatile induction and maintenance of anaesthesia (VIMA group, n = 20, sevoflurane + fentanyl). All patients were operated using temporary carotid bypass. Invasive arterial pressure (AP), gas exchange, and cerebral tissue oxygen saturation (SctO2, ForeSight, CAsMed, USA) over frontal region for ipsilateral (SctO2IPSI) and contralateral (SctO2CONTR) hemispheres were registered during the surgery and up to 20 hrs of the postoperative period. The cognitive changes will be assessed at 12 hrs before as well as on Days 1 and 5 after CEE by blinded investigator using Montreal Cognitive Assessment score (MoCA).
Data will be presented as median (25-75th percentiles). Intergroup comparison will be provided with Mann-Whitney U-test and correlation analysis with Spearman's coefficient (rho). P value below 0.05 was regarded as statistically significant.
- Being tested
- Propofol, Sevoflurane, Elective carotid endarterectomy
- Keywords
- Carotid endarterectomy, postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Tital intravenous anesthesia (TIVA)
Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention
SevofluraneDrug
Also called Volatile induction and maintenance of anesthesia (VIMA)
Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention
Elective carotid endarterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TIVA with propofol | Sham comparator | Induction and maintenance of general anesthesia using TIVA with propofol Receives: Drug: Propofol; Procedure: Elective carotid endarterectomy |
| VIMA with sevoflurane | Active comparator | Induction and maintenance of general anesthesia using VIMA with sevoflurane Receives: Drug: Sevoflurane; Procedure: Elective carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative cognitive dysfunction
Postoperative cognitive dysfunction assessed with MoCA score
Measured: 5 Days of the perioperative period
Secondary outcomes (1)
Cerebral desaturation
Cerebral tissue oxygen saturation monitored intra- and postoperatively with non-invasive cerebral tissue oximeter
Measured: 0-20 hrs of the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndarterectomyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vsevolod V. Kuzkov, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771418
- Sponsor's protocol ID
- CEE-VIMA
- Acronym
- CEE-VIMA
- Status last verified
- Sep 2016
- First submitted
- 6 May 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will be published in the peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anaesthesia on Cerebral Oxygenation and Cognitive Function in Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT02771418
- Acronym / sponsor ID
- CEE-VIMA / CEE-VIMA
- Keywords
- Carotid endarterectomy, postoperative cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 May 2016 (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.
Volatile anesthetics interfere with cerebral blood flow and reperfusion-ischemia injury via the mechanism known as a preconditioning. A transient deterioration of local hemodynamics and oxygenation during carotid endarterectomy (CEE) might involve both hemispheres of brain and affect postoperative cognitive function. The goal of this study was to assess the effects of anesthetics on perioperative cerebral oxygenation and cognitive functions.
Detailed description
Background: A transient deterioration of cerebral hemodynamics and oxygenation during CEE might involve both hemispheres of the brain and affects postoperative cognition. Despite some benefits of regional blocks, the majority of procedures of carotid endarterectomy (CEE) are performed under general anaesthesia. Surprisingly, the studies comparing the effects of sevoflurane and propofol on postoperative mental state in CEE are scarce and controversial. While propofol possesses some anti-inflammatory properties, volatile anesthetics can interfere with cerebral blood flow and reperfusion-ischaemia injury via the mechanism of pre- and postconditioning. The goal of this study is to assess the effects of the anesthetics on the perioperative cerebral oxygenation and cognitive functions in CEE.
Methods: The study and informed consent are approved by the Ethical Committee of the Northern State Medical University. Forty patients (males only) who are to undergo elective CEE will be included into a prospective study and randomised to two groups receiving either total intravenous anaesthesia (TIVA group, propofol + fentanyl) or the volatile induction and maintenance of anaesthesia (VIMA group, n = 20, sevoflurane + fentanyl). All patients were operated using temporary carotid bypass. Invasive arterial pressure (AP), gas exchange, and cerebral tissue oxygen saturation (SctO2, ForeSight, CAsMed, USA) over frontal region for ipsilateral (SctO2IPSI) and contralateral (SctO2CONTR) hemispheres were registered during the surgery and up to 20 hrs of the postoperative period. The cognitive changes will be assessed at 12 hrs before as well as on Days 1 and 5 after CEE by blinded investigator using Montreal Cognitive Assessment score (MoCA).
Data will be presented as median (25-75th percentiles). Intergroup comparison will be provided with Mann-Whitney U-test and correlation analysis with Spearman's coefficient (rho). P value below 0.05 was regarded as statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA with propofol | Sham comparator | Drug: Propofol, Procedure: Elective carotid endarterectomyInduction and maintenance of general anesthesia using TIVA with propofol |
| VIMA with sevoflurane | Active comparator | Drug: Sevoflurane, Procedure: Elective carotid endarterectomyInduction and maintenance of general anesthesia using VIMA with sevoflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- Male gender
- Informed consent
- Symptomatic carotid stenosis > 75%
Key exclusion criteria (2 listed)
- Contralateral carotid occlusion
- Known allergy to the one of the compared medications
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: Tital intravenous anesthesia (TIVA)Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention | Drug | TIVA with propofol |
| SevofluraneAlso: Volatile induction and maintenance of anesthesia (VIMA)Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention | Drug | VIMA with sevoflurane |
| Elective carotid endarterectomy | Procedure or surgery | TIVA with propofol, VIMA with sevoflurane |
Primary outcome
Early postoperative cognitive dysfunction
Time frame: 5 Days of the perioperative period
Postoperative cognitive dysfunction assessed with MoCA score
1 secondary outcome
Cerebral desaturation
Time frame: 0-20 hrs of the perioperative period
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 22 Sep 2016.
- Individual participant dataSharing planned: Yes. Will be published in the peer-reviewed journal
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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 study testing Propofol, Sevoflurane and Elective carotid endarterectomy in people with Endarterectomy and Postoperative Cognitive Dysfunction, run by Northern State Medical University at 1 site in Russia.
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 4 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 22 Sep 2016. 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 Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Early postoperative cognitive dysfunction (time frame: 5 Days of the perioperative period). 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 22 Sep 2016.