Clinical trial NCT06183567: The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy
Official title: The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Anesthesia
Neurologic Symptoms
Keywords: general anesthesia
sedoanalgesia
neurological outcome
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were divided into two groups as sedoanalgesia group (SA=31 patients) and general anesthesia group (GA=31 patients).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: scoring systems of neurological findings
timeFrame: Before Endovascular Thrombectomy and after 48 hours
measure: effects of both anesthesia management on hemodynamics during the procedure
timeFrame: Before the Endovascular Thrombectomy procedure and until the end of the recovery period (4 hours)
Secondary outcomes:
measure: early neurological outcome findings
timeFrame: 48 hours
measure: mortality and morbidity
timeFrame: hospitalization days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research Hospital
state: Umraniye
Study officials:
References: