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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Stroke; Anesthesia; Neurologic Symptoms
• Intervention / Treatment: Procedure: Sedoanalgesia; Procedure: general anesthesia

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Umraniye
    • Istanbul, Umraniye, Turkey (Türkiye), 34734
      • Umraniye Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sedoanalgesia (SA) group; The aim was to achieve a moderate level of sedoanalgesia (previously called conscious sedation) that would reduce agitation, anxiety and mobility but allow communication with the patient. Sedation was maintained at a level where cardiovascular function was preserved and no intervention was required to protect the airway in spontaneous breathing. Fentanyl iv 25-50 µg bolus was administered to each patient undergoing sedoanalgesia. For maintenance of sedoanalgesia, propofol iv infusion was started at doses of 1-2 mg kg-1 hour. It was titrated according to BIS level. In case of patient noncompliance, propofol iv 0.5 mg kg-1 was intervened.	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.
Active Comparator: General anesthesia (GA) group; Anesthesia induction was performed with lidocaine iv 0.5 mg kg-1, propofol iv 1-2 mg kg-1, fentanyl iv 25-50 µg. After providing adequate ventilation with a mask, rocuronium iv 0.45-0.6 mg kg-1 is administered and endotracheal intubation is performed. After intubation is confirmed with end-tidal CO2 monitoring, tidal volume is set to 6-8 ml kg-1 and respiratory frequency to 12/min in CMV mode. In order to maintain cerebral perfusion, PaCO2: 35-40 mmHg is aimed to be maintained. Sevoflurane MAC 0.8 and remifentanil infusion 0.03 µg kg-1 min iv were used for maintenance of anesthesia. At the end of the procedure, sugammadex iv 2mg kg-1 was administered for extubation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
early neurological outcome findings	hemiparesis, hemiplegia, aphasia, facial paralysis	48 hours
mortality and morbidity	exitus,discharge to home or palliative unit	hospitalization days

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: general anesthesia; neurological outcome; sedoanalgesia
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ischemic Stroke; Neurologic Manifestations; Anesthesia and Analgesia; Anesthesia; Anesthesia, General
• Other Study ID Numbers: UERH-AR-ZT-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No