Ischemic StrokeNCT06183567
The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy
A study testing Sedoanalgesia and general anesthesia in people with Ischemic Stroke and Anesthesia, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Anesthesia, Neurologic Symptoms
- What is being tested?
- Sedoanalgesia and general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, Umraniye, 34734
About this study
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.
Read the 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
- Being tested
- Sedoanalgesia, general anesthesia
- Keywords
- general anesthesia, sedoanalgesia, neurological outcome
- Medical subject headings
- Ischemic Stroke, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedoanalgesiaProcedure or surgery
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 anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sedoanalgesia; Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
scoring systems of neurological findings
NIHSS (National Institutes of Health Stroke Scale), Glasgow coma scale (GCS) and FOUR (Full Outline of UnResponsiveness) scores
Measured: Before Endovascular Thrombectomy and after 48 hours
effects of both anesthesia management on hemodynamics during the procedure
Mean arterial pressure, heart rate
Measured: Before the Endovascular Thrombectomy procedure and until the end of the recovery period (4 hours)
Secondary outcomes (2)
early neurological outcome findings
hemiparesis, hemiplegia, aphasia, facial paralysis
Measured: 48 hours
mortality and morbidity
exitus,discharge to home or palliative unit
Measured: hospitalization days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start30 Nov 2023
- Primary completion30 Dec 2025
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were divided into two groups as sedoanalgesia group (SA=31 patients) and general anesthesia group (GA=31 patients).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183567
- Sponsor's protocol ID
- UERH-AR-ZT-04
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sedoanalgesia and General Anaesthesia on Early Neurological Recovery in Acute Ischaemic Stroke Patients Undergoing Endovascular Thrombectomy
- ClinicalTrials.gov ID
- NCT06183567
- Acronym / sponsor ID
- UERH-AR-ZT-04
- Conditions
- Ischemic Stroke, Anesthesia, Neurologic Symptoms
- Keywords
- general anesthesia, sedoanalgesia, neurological outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients were divided into two groups as sedoanalgesia group (SA=31 patients) and general anesthesia group (GA=31 patients).
| Arm | Type | Receives |
|---|---|---|
| Sedoanalgesia (SA) group | Active comparator | Procedure: Sedoanalgesia, Procedure: general anesthesiaThe 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. |
| General anesthesia (GA) group | Active comparator | Procedure: Sedoanalgesia, Procedure: general anesthesiaAnesthesia 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- Chronic renal failure
- EF less than 40
- Presence of intracranial hemorrhage
- Previous known history of severe neurological disease
- Presence of bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SedoanalgesiaIn 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 or surgery | General anesthesia (GA) group, Sedoanalgesia (SA) group |
| general anesthesiaIn 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. | Procedure or surgery | General anesthesia (GA) group, Sedoanalgesia (SA) group |
Primary outcome
scoring systems of neurological findings
Time frame: Before Endovascular Thrombectomy and after 48 hours
NIHSS (National Institutes of Health Stroke Scale), Glasgow coma scale (GCS) and FOUR (Full Outline of UnResponsiveness) scores
effects of both anesthesia management on hemodynamics during the procedure
Time frame: Before the Endovascular Thrombectomy procedure and until the end of the recovery period (4 hours)
Mean arterial pressure, heart rate
2 secondary outcomes
early neurological outcome findings
Time frame: 48 hours
mortality and morbidity
Time frame: hospitalization days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedoanalgesia and general anesthesia in people with Ischemic Stroke and Anesthesia, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scoring systems of neurological findings (time frame: Before Endovascular Thrombectomy and after 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.