The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy

Anesthesia Clinical Trial

Official title:

The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06183567
• Other study ID #: UERH-AR-ZT-04
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this study is that sedoanalgesia will provide better early neurological recovery than general anaesthesia in acute ischaemic stroke patients undergoing endovascular thrombectomy and to investigate the haemodynamic data of both anaesthetic methods.

Description:

Endovascular mechanical thrombectomy (EMT) is the standard emergency treatment for patients presenting with acute ischemic stroke in the anterior circulation due to urgent large vessel occlusion and suitable for interventional procedures. However, despite reperfusion of the ischemia-affected area, some patients do not recover clinically. The reason for this is not known exactly. It is known that age and baseline function, which are thought to indicate brain reserve, affect the long-term outcome of stroke. Chronic hypertension, diabetes mellitus, dyslipidemia and coronary artery disease, which are associated with low brain reserve, are quite common in acute ischemic stroke patients. There is controversy as to whether general anesthesia (GA) or sedoanalgesia (SA) should be used during EMT for acute ischemic stroke. There are not enough randomized trials addressing this question. Benefits of GA include airway preservation, pain control and potentially improved radiographic imaging and patient immobility for intervention. Conversely, GA is time-consuming and possibly associated with longer time for groin puncture and revascularization. In addition, hypotension may occur during GA, which carries a greater risk of ischemic damage. Advantages of SA may include shorter time to revascularization, fewer hemodynamic problems and the possibility of better neurological assessment during the procedure. The main arguments against SA are that patient movement can lead to procedural complications, higher radiation dose, the need for more contrast media and lack of airway control. Simonsen et al. compared general anesthesia and conscious sedation in patients with acute ischemic stroke undergoing endovascular treatment (GOLIATH) and showed that the choice of different anesthesia method can affect infarct area growth, clinical outcomes, and important physiological and anesthetic parameters. Again, in the SIESTA (Sedation vs Intubation for Endovascular Stroke Treatment) study comparing sedation and intubation in endovascular stroke treatment, no significant difference was shown between both groups when early neurological recovery was compared (24th hour NIHSS). In this study, no superiority of conscious sedation over general anesthesia was demonstrated. In the ESCAPE and SWIFT study, general anesthesia and conscious sedation were compared and conscious sedation was associated with better outcome than general anesthesia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: May 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Presence of cerebral ischemic embolism within the first 6 hours

2. ASA 1-4

3. Body mass index below 30 kg m-2

4. NIHSS score = 10

5. Presence of isolated/combined occlusion at any level of the anterior circulation internal carotid or middle cerebral artery

Exclusion Criteria:

• Chronic renal failure
• EF less than 40
• Presence of intracranial hemorrhage
• Previous known history of severe neurological disease
• Presence of bleeding diathesis
• Pre-procedure GCS = 8 and intubated patients
• Failure to clearly show the site of vascular occlusion on diagnostic imaging results
• Clinical or imaging evidence of vascular occlusion that is not internal carotid artery or middle cerebral artery
• Absence of gag reflex, loss of airway protective reflex, inadequate saliva swallowing
• History of lung infection, advanced COPD or respiratory failure
• Known history of aspiration due to vomiting,
• Known history of difficult airway
• In the presence of known intolerance or allergy to certain drugs for sedation, analgesia or both
• Previously known carotid artery stenosis
• Pregnant patients
• Patients without consent

Related Conditions & MeSH terms

• Anesthesia
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Neurologic Manifestations
• Neurologic Symptoms
• Stroke

Intervention

Procedure:
• Sedoanalgesia
In Acute Ischemic Stroke Patients Undergoing Endovascular Thrombectomy, the procedure was performed under sedoanalgesia. The procedure was continued with mean arterial pressure, heart rate, pulse oximetry and BIS monitoring.
• general anesthesia
In Acute Ischemic Stroke Patients Undergoing Endovascular Thrombectomy, the procedure was performed under general anesthesia. The procedure was continued with mean arterial pressure, heart rate, pulse oximetry and BIS monitoring.

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research Hospital	Istanbul	Umraniye

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scoring systems of neurological findings	NIHSS (National Institutes of Health Stroke Scale), Glasgow coma scale (GCS) and FOUR (Full Outline of UnResponsiveness) scores	Before Endovascular Thrombectomy and after 48 hours
Primary	effects of both anesthesia management on hemodynamics during the procedure	Mean arterial pressure, heart rate	Before the Endovascular Thrombectomy procedure and until the end of the recovery period (4 hours)
Secondary	early neurological outcome findings	hemiparesis, hemiplegia, aphasia, facial paralysis	48 hours
Secondary	mortality and morbidity	exitus,discharge to home or palliative unit	hospitalization days