Association Between Local Cerebral Oxygenation Monitoring and Postoperative Stroke in Carotid Endarterectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital
About this trial
Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (COx) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective carotid endarterectomy
ASA Ⅱ or Ⅲ
aged 18-80 years old
Disqualifiers
preoperative moderate and severe cognitive impairment
preoperative psychotropic medication history within one year
history of neurosurgery
have speech or language impairments
Trial design
Design model
Parallel
Treatments tested in this trial
Cerebral oxygenation index guided hemodynamics management
Other interventionIn the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, norepinephrine or phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation.
Treatment groups
560 Participants
are divided into 2 treatment groupsGroup A: The autoregulation groupExperimental treatment 1 intervention
Group B: The routine groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The incidence of postoperative cerebral ischemic events
Our primary outcome will be the incidence of new ischemic brain injury within 3 days after surgery, defined as new infarct focus detected by magnetic resonance imaging diffusion-weighted imaging or computed tomography, with or without new-onset limb weakness, paresthesia, or language abnormalities. Diffusion-weighted imaging sequences will be used at each scan to detect acute ischemic brain lesions.
Time frame
postoperative 3 daySecondary outcomes
1
The incidence of postoperative delirium
The incidence and severity of postoperative delirium will be assessed during the first 3 days after surgery. Delirium will be assessed twice daily between 8:00-10:00 and 18:00-20:00 in ward patients with the Richmond Agitation Sedation Scale (RASS) and the 3 min diagnostic interview for CAM (3D-CAM). ICU patients will be similarly assessed with RASS and the confusion assessment method for ICU (CAM-ICU). Any positive 3D-CAM or CAM-ICU assessment will be considered evidence of delirium.
Time frame
The first 3 days after surgery2
Basic Cognition Assessment
Postoperative basic cognitive function will be assessed by Mini-mental State Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.
Time frame
The day before surgery and postoperative day 4 or 53
Advanced Cognitive Assessment
Postoperative basic cognitive function will be assessed by Montreal Cognitive Assessment-Basic Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.
Time frame
The day before surgery and postoperative day 4 or 54
Pain assessment
Pain scores will be recorded at rest and during movement . The pain was rated on a scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst possible pain. Higher scores corresponded to higher levels of pain.
Time frame
At 24, 48, and 72 hours post-surgerySponsors and contacts
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Source ClinicalTrials.gov