Transient Ischemic AttackNCT03622515
the Research of the Cerebral Protection Effects of Electroencephalogram (SedLine) During Carotid Endarterectomy
A study testing Anesthesia level and cerebral perfusion pressure in people with Transient Ischemic Attack and Acute Stroke, run by Beijing Municipal Administration of Hospitals at 2 sites in China.
Trial summary
Fragile brain is the most common phenomenon seen in the patients undergoing CEA. The patients with fragile brain have a high incidence of postoperative brain dysfunction. This study intends to apply EEG monitoring (Sedline) to CEA to investigate whether EEG monitoring can reduce the incidence of postoperative… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transient Ischemic Attack, Acute Stroke, Postoperative Delirium
- What is being tested?
- Anesthesia level and cerebral perfusion pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesChina
- Study dates
- 10 Aug 2018to 12 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective carotid endarterectomy;
- All those who agree to join the trial and sign the informed consent form;
- ASAI to III.
Who cannot join
- Those who refuse to sign the informed consent form;
- ASA Level IV and above;
- Unstable angina or acute myocardial infarction within 4 to 6 weeks before surgery, and heart function NYHA III to IV;
- Those with severe liver and kidney function diseases;
- Preoperative combined cognitive impairment; [MMSE reference demarcation value: illiterate (uneducated) group ≤ 19 points, primary school (education years ≤ 6 years) group ≤ 22 points, secondary school or above (education years) 6 years) group ≤26 points; MoCA reference demarcation value: illiterate ≤13, primary school ≤19, middle school and above ≤24. ]
- Preoperative combined anxiety and depression; (SDS or SAS>41 points)
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- Patients with an endotracheal intubation returning to the ICU;
- severe allergic reactions, major bleeding, etc. during surgery, causing severe fluctuations in hemodynamics;
- The subject actively requested to withdraw from the study or to be lost to follow-up.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Na XU, 8613810001662, xinan_xu@126.com
- Recruiting
Xuanwu hospital Captial Medical University
Beijing, Beijing Municipality, 100053
Na XU, 8613810001662, xinan_xu@126.com
About this study
Official title: Xuanwu Hospital Capital Medical University
Fragile brain is the most common phenomenon seen in the patients undergoing CEA. The patients with fragile brain have a high incidence of postoperative brain dysfunction. This study intends to apply EEG monitoring (Sedline) to CEA to investigate whether EEG monitoring can reduce the incidence of postoperative neurological complications in CEA patients and improve their prognosis.
220 patients with CEA were randomly divided into 2 groups. Group S [Sedline monitoring + Transcranial Doppler (TCD) + regional cerebral oxygen saturation (rS02)，n=110] and group C [Bispectral index (BIS)/Sedline monitoring + TCD +rSO2,n=110], recording intraoperative and postoperative conditions, neuropsychology scale assessment, blood examination and imaging examination. The incidence of postoperative neurological complications was compared between the two groups.
- Conditions
- Transient Ischemic Attack, Acute Stroke, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Being tested
- Anesthesia level and cerebral perfusion pressure
- Medical subject headings
- Ischemic Attack, Transient, Stroke, Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia level and cerebral perfusion pressureCombination product
Anesthetic dose and blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Sedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure Receives: Combination Product: Anesthesia level and cerebral perfusion pressure |
| Group C | No intervention | Bispectral index (BIS)/Sedline monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change from baseline of neurological complications before operation
Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.
Measured: after operation
Secondary outcomes (1)
the change from baseline of other complications before operation
acute myocardial infarction, heart failure, arrhythmia, pulmonary infection, atelectasis, acute kidney injury, etc.
Measured: 3 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start10 Aug 2018
- Primary completion12 Apr 2022
- Study completion12 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, XU Na, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622515
- Sponsor's protocol ID
- ZYLX201818
- Status last verified
- Apr 2022
- First submitted
- 29 Jul 2018
- Last updated
- 13 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu N, Li LX, Wang TL, Jiao LQ, Hua Y, Yao DX, Wu J, Ma YH, Tian T, Sun XL. Processed Multiparameter Electroencephalogram-Guided General Anesthesia Management Can Reduce Postoperative Delirium Following Carotid Endarterectomy: A Randomized Clinical Trial. Front Neurol. 2021 Jul 12;12:666814. doi: 10.3389/fneur.2021.666814. eCollection 2021.
PubMed 34322079
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xuanwu Hospital Capital Medical University
- ClinicalTrials.gov ID
- NCT03622515
- Acronym / sponsor ID
- ZYLX201818
- Conditions
- Transient Ischemic Attack, Acute Stroke, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (estimated)
- First posted
- 9 Aug 2018 (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.
Fragile brain is the most common phenomenon seen in the patients undergoing CEA. The patients with fragile brain have a high incidence of postoperative brain dysfunction. This study intends to apply EEG monitoring (Sedline) to CEA to investigate whether EEG monitoring can reduce the incidence of postoperative neurological complications in CEA patients and improve their prognosis.
220 patients with CEA were randomly divided into 2 groups. Group S [Sedline monitoring + Transcranial Doppler (TCD) + regional cerebral oxygen saturation (rS02)，n=110] and group C [Bispectral index (BIS)/Sedline monitoring + TCD +rSO2,n=110], recording intraoperative and postoperative conditions, neuropsychology scale assessment, blood examination and imaging examination. The incidence of postoperative neurological complications was compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Combination Product: Anesthesia level and cerebral perfusion pressureSedline monitoring Adjust the depth of anesthesia by adjusting the amount of anesthesia, and adjust the cerebral perfusion pressure by adjusting blood pressure |
| Group C | No intervention | –Bispectral index (BIS)/Sedline monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective carotid endarterectomy;
- All those who agree to join the trial and sign the informed consent form;
- ASAI to III.
Key exclusion criteria (9 listed)
- Those who refuse to sign the informed consent form;
- ASA Level IV and above;
- Unstable angina or acute myocardial infarction within 4 to 6 weeks before surgery, and heart function NYHA III to IV;
- Those with severe liver and kidney function diseases;
- Preoperative combined cognitive impairment; [MMSE reference demarcation value: illiterate (uneducated) group ≤ 19 points, primary school (education years ≤ 6 years) group ≤ 22 points, secondary school or above (education years) 6 years) group ≤26 points; MoCA reference demarcation value: illiterate ≤13, primary school ≤19, middle school and above ≤24. ]
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 |
|---|---|---|
| Anesthesia level and cerebral perfusion pressureAnesthetic dose and blood pressure | Combination product | Group S |
Primary outcome
the change from baseline of neurological complications before operation
Time frame: after operation
Transient ischemic attack, acute stroke, postoperative delirium, postoperative cognitive dysfunction, etc.
1 secondary outcome
the change from baseline of other complications before operation
Time frame: 3 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 34322079Xu N, Li LX, Wang TL, Jiao LQ, Hua Y, Yao DX, Wu J, Ma YH, Tian T, Sun XL. Processed Multiparameter Electroencephalogram-Guided General Anesthesia Management Can Reduce Postoperative Delirium Following Carotid Endarterectomy: A Randomized Clinical Trial. Front Neurol. 2021 Jul 12;12:666814. doi: 10.3389/fneur.2021.666814. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia level and cerebral perfusion pressure in people with Transient Ischemic Attack and Acute Stroke, run by Beijing Municipal Administration of Hospitals at 2 sites 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change from baseline of neurological complications before operation (time frame: after operation). 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 NCT03622515, which also lists 1 linked publication.
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 13 Apr 2022.