NCT06183567

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Umraniye Education and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke
• Anesthesia
• Neurologic Symptoms

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2023-11-30
• Primary completion: 2025-12-30
• Completion: 2026-07-30
• First posted: 2023-12-27
• Last updated: 2025-11-19

Locations

1 site across 1 country: Turkey (Türkiye)