A Phase 4 interventional study of Sedation and General Anesthesia (GA) in Stroke, sponsored by The University of Texas Health Science Center, Houston. Completed at 11 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
Objectives:
This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life.
Hypothesis:
GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.
Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT):
Anterior Cerebral Artery (ACA) A1 or proximal A2
Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines
i. Ischemic core by CT Perfusion or MRI/MR Perfusion \< 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of \< 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core \< 51 mL.
Exclusion Criteria:
The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist.
Drug: Sedation · Procedure: Intra-arterial Thrombectomy
The protocol does not specify a particular combination of drugs that must be used for general anesthesia. The choice of specific drugs and dosages for achieving general anesthesia will be up to the anesthesiologist.
Drug: General Anesthesia (GA) · Procedure: Intra-arterial Thrombectomy
The protocol does not specify a particular combination of drugs that must be used for sedation. The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist. The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)
The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.
Also known as: Endovascular Therapy
Modified Ordinal Rankin Scale (mRS)
mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
Time frame: 90 days
Dichotomized Modified Ordinal Rankin Scale (mRS)
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 2 categories are reported: number of participants who had a score of 0-2, and number who had a score of 3-6. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
Time frame: 90 days
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b
The thrombolysis in cerebral infarction (TICI) grading system is a tool for determining the response of thrombolytic therapy for ischemic stroke. The TICI grade ranges from 0 to 3, with a higher score indicating greater perfusion. grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
Time frame: post procedure within 6 hours
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a tool used objectively quantify the impairment caused by a stroke. Total score ranges from 0 - 42, with a higher score indicating greater severity of impairment caused by stroke. 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Time frame: 24-36 hours post procedure
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
Time frame: 90 days
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment
The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Time frame: 90 days
Number of Participants With Symptomatic Intracerebral Hemorrhage
Symptomatic intracerebral hemorrhage was defined using the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition, a ≥ 4 point increase in NIHSS score with a parenchymal hemorrhage type 2 within 36 hours.
Time frame: 18-36 hours post procedure
Number of Participants With All-cause Mortality
Time frame: 18-36 hours post procedure
Number of Participants With Procedural Complications
Time frame: 18-36 hours post procedure
Time From Groin Puncture to Reperfusion
Time frame: post procedure within 6 hours
Time From Door to TICI ≥ 2b Reperfusion
Time frame: post procedure within 6 hours
| Milestone | Sedation | General Anesthesia |
|---|---|---|
| Started | 130 | 130 |
| Pass screening | 129 | 128 |
| Completed | 120 | 120 |
| Not completed | 10 | 10 |
mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
| Participants | General Anesthesia | Sedation |
|---|---|---|
| score of 0 | 16 | 11 |
| score of 1 | 21 | 23 |
| score of 2 | 20 | 13 |
| score of 3 | 21 | 24 |
| score of 4 | 9 | 16 |
| score of 5 or 6 | 33 | 33 |
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 2 categories are reported: number of participants who had a score of 0-2, and number who had a score of 3-6. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
| Participants | General Anesthesia | Sedation |
|---|---|---|
| Score of 0, 1, or 2 | 57 | 47 |
| Score of 3, 4, 5, or 6 | 63 | 73 |
The thrombolysis in cerebral infarction (TICI) grading system is a tool for determining the response of thrombolytic therapy for ischemic stroke. The TICI grade ranges from 0 to 3, with a higher score indicating greater perfusion. grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
| Participants | General Anesthesia | Sedation |
|---|---|---|
| Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b | 118 | 116 |
The National Institutes of Health Stroke Scale (NIHSS) is a tool used objectively quantify the impairment caused by a stroke. Total score ranges from 0 - 42, with a higher score indicating greater severity of impairment caused by stroke. 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
| score on a scale | General Anesthesia | Sedation |
|---|---|---|
| Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) | 7 (3 to 14) | 6 (3 to 14) |
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
| Participants | General Anesthesia | Sedation |
|---|---|---|
| Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2 | 57 | 47 |
The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
| score on a scale | General Anesthesia | Sedation |
|---|---|---|
| Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment | 0.47 ± 0.44 | 0.46 ± 0.40 |
Symptomatic intracerebral hemorrhage was defined using the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition, a ≥ 4 point increase in NIHSS score with a parenchymal hemorrhage type 2 within 36 hours.
| Participants | General Anesthesia | Sedation |
|---|---|---|
| Number of Participants With Symptomatic Intracerebral Hemorrhage | 1 | 3 |
| Participants | General Anesthesia | Sedation |
|---|---|---|
| Number of Participants With All-cause Mortality | 11 | 9 |
| Participants | General Anesthesia | Sedation |
|---|---|---|
| Number of Participants With Procedural Complications | 4 | 5 |
| minutes | General Anesthesia | Sedation |
|---|---|---|
| Time From Groin Puncture to Reperfusion | 41 (25 to 66) | 43 (29 to 65) |
| minutes | General Anesthesia | Sedation |
|---|---|---|
| Time From Door to TICI ≥ 2b Reperfusion | 121 (90 to 149) | 116 (93 to 138) |
Collected over from baseline to 90 days after discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| General Anesthesia | 11/130 (8.5%) | 62/130 (47.7%) | 0/130 (0%) |
| Sedation | 9/130 (6.9%) | 65/130 (50%) | 0/130 (0%) |
| Event | General Anesthesia | Sedation |
|---|---|---|
| intracerebral hemorrhage asymptomaticVascular disorders | 59/130 | 59/130 |
| Procedure ComplicationsSurgical and medical procedures | 4/130 | 5/130 |
| intracerebral hemorrhage symptomaticVascular disorders | 1/130 | 3/130 |
Baseline characteristics were only collected for participants who were randomized and pass screening.
| Age, Continuous(years) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Mean | 65.9 ± 12.7 | 67.6 ± 13.8 | 66.77 ± 13.28 |
| Sex: Female, Male(Participants) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Female | 69 | 55 | 124 |
| Male | 59 | 74 | 133 |
| Ethnicity (NIH/OMB)(Participants) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Hispanic or Latino | 23 | 21 | 44 |
| Not Hispanic or Latino | 98 | 100 | 198 |
| Unknown or Not Reported | 7 | 8 | 15 |
| Race/Ethnicity, Customized(Participants) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Race — White | 64 | 65 | 129 |
| Race — Black | 38 | 37 | 75 |
| Race — Asian | 3 | 2 | 5 |
| Race — More than one race | 7 | 7 | 14 |
| Race — Unknown | 16 | 18 | 34 |
| Region of Enrollment(participants) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| United States | 128 | 129 | 257 |
| Number of Participants who received intravenous tissue-type plasminogen activator treatment(Participants) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Count of participants | 78 | 72 | 150 |
| Number of Participants with Atrial Flutter/Atrial Fibrillation(Participants) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Count of participants | 23 | 32 | 55 |
| Number of Participants with a history of diabetes(Participants) | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Count of participants | 26 | 34 | 60 |
14 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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The University of Texas Health Science Center, Houston