Trials / Unknown
UnknownNCT05493813
Total Intravenous Anesthesia Versus Sevoflurane Anesthesia for Endovascular Thrombectomy in Acute Ischemic Stroke
Target-controlled Total Intravenous Anesthesia With Propofol Versus Sevoflurane Anesthesia for Endovascular Thrombectomy Procedure in Acute Ischemic Stroke Patients: Comparison of the Outcomes
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 298 (estimated)
- Sponsor
- Taipei Veterans General Hospital, Taiwan · Other Government
- Sex
- All
- Age
- 20 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The present clinical trial compares the effect of two general anesthesia (GA) modalities, the one with volatile anesthetic sevoflurane (endotracheal-intubated) and the other integrating total intravenous anesthesia (TIVA) with propofol (non-intubated), on post-procedural delirium and cognitive dysfunction after endovascular thrombectomy (EVT) in the participants with acute ischemic stroke. To assess the outcome of both modalities, the sedation depth of GA will be regulated with processed electroencephalogram monitor to reduce the incidence of postoperative delirium and the peri-procedural blood pressure will be controlled according to the guideline.Based on that, the investigators try to find a better general anesthetic modality for acute ischemic stroke participants undergoing EVT.
Detailed description
1. In 2019, cerebrovascular disease (i.e., stroke) was the second leading cause of death worldwide. 2. The present guidelines for the early management of the participants with acute ischemic stroke urge the in-time and early application of intravenous chemical thrombolysis and endovascular thrombectomy (EVT) due to better outcome and prognosis. "Timing is brain." 3. The participants with acute ischemic stroke, previous stroke, and severe stroke have high incidence of delirium, and the stroke-related delirium has been shown to correlate with higher morbidity and mortality. 4. Researches on the anesthetic management during EVT for acute ischemic stroke have shown that both general anesthesia and sedation anesthesia are safe and without difference in neurological outcome and long-term complications. However, general anesthesia might have higher rates in revascularization in EVT for acute ischemic stroke as compared with sedation anesthesia. 5. Anesthesia could produce postoperative cognitive dysfunction (POCD) or delirium (POD), and general anesthesia could produce higher rates of POCD and POD compared to general anesthesia and sedation anesthesia. Additionally, brain injury and acute ischemic stroke are independent risk factors for POCD and POD. Whether the anesthetic management for EVT would interfere with the acute ischemic stroke-produced POCD and/or POD or even delay the detection and treatment of stroke-related neurological impairment deserves investigation since EVT is the gold standard for acute ischemic stroke.
Conditions
- Ischemic Stroke, Acute
- Thrombectomy
- General Anesthesia
- Total Intravenous Anesthesia
- Postoperative Delirium
- Postoperative Cognitive Dysfunction
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive function and delirium evaluation | Cognitive functions (including delirium) will be assessed pre-procedure (baseline) and emergency department (before EVT), on day 1 and 7 and 3 months after EVT procedure |
| BEHAVIORAL | Neurological functional assessment | National Institute of Health Stroke Scale (NIHSS) and modified Rankin scale (mRS) will be assessed before (baseline but after stroke) and after EVT on days 1 and 7 after procedure up to 3 months follow-up. |
Timeline
- Start date
- 2022-02-15
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
- First posted
- 2022-08-09
- Last updated
- 2023-02-22
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT05493813. Inclusion in this directory is not an endorsement.