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

NCT06183567 | Active Not Recruiting

• 1 other identifier: UERH-AR-ZT-04
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Anesthesia; Neurologic Symptoms

Keywords

general anesthesia; sedoanalgesia; neurological outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• early neurological outcome findings

  48 hours

• mortality and morbidity

  hospitalization days

Study Arms (2)

Sedoanalgesia (SA) group

ACTIVE COMPARATOR

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; Procedure: general anesthesia

General anesthesia (GA) group

ACTIVE COMPARATOR

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; Procedure: general anesthesia

Interventions

Sedoanalgesia PROCEDURE

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 (GA) group; Sedoanalgesia (SA) group

general anesthesia PROCEDURE

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.

General anesthesia (GA) group; Sedoanalgesia (SA) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of cerebral ischemic embolism within the first 6 hours
• ASA 1-4
• Body mass index below 30 kg m-2
• NIHSS score ≥ 10
• Presence of isolated/combined occlusion at any level of the anterior circulation internal carotid or middle cerebral artery

You may not qualify if:

• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke; Neurologic Manifestations

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study was double-blinded, patients were selected by closed envelope method, and different clinicians administered anesthesia and postoperative follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology and Reanimation department,Assoc Prof

Model Details: Patients were divided into two groups as sedoanalgesia group (SA=31 patients) and general anesthesia group (GA=31 patients).

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: November 30, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)