Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-12-13
Brief Title:
The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy
Sponsor:
Umraniye Education and Research Hospital
Organization:
Umraniye Education and Research Hospital
Study Overview
Official Title:
The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None