Trial Outcomes & Findings for SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke (NCT NCT03263117)
NCT ID: NCT03263117
Last Updated: 2025-11-26
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
260 participants
Primary outcome timeframe
90 days
Results posted on
2025-11-26
Participant Flow
Participant milestones
| Measure |
Sedation
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
General Anesthesia
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
130
|
|
Overall Study
Pass screening
|
129
|
128
|
|
Overall Study
COMPLETED
|
120
|
120
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were not collected from 56 participants in the general anesthesia arm and 65 participants in the sedation arm because the stroke onset was not witnessed, therefore the stroke onset time could not be collected.
Baseline characteristics by cohort
| Measure |
General Anesthesia
n=128 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=129 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 12.7 • n=128 Participants
|
67.6 years
STANDARD_DEVIATION 13.8 • n=129 Participants
|
66.77 years
STANDARD_DEVIATION 13.28 • n=257 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=128 Participants
|
55 Participants
n=129 Participants
|
124 Participants
n=257 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=128 Participants
|
74 Participants
n=129 Participants
|
133 Participants
n=257 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=128 Participants
|
21 Participants
n=129 Participants
|
44 Participants
n=257 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=128 Participants
|
100 Participants
n=129 Participants
|
198 Participants
n=257 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=128 Participants
|
8 Participants
n=129 Participants
|
15 Participants
n=257 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
64 Participants
n=128 Participants
|
65 Participants
n=129 Participants
|
129 Participants
n=257 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
38 Participants
n=128 Participants
|
37 Participants
n=129 Participants
|
75 Participants
n=257 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=128 Participants
|
2 Participants
n=129 Participants
|
5 Participants
n=257 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
7 Participants
n=128 Participants
|
7 Participants
n=129 Participants
|
14 Participants
n=257 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
16 Participants
n=128 Participants
|
18 Participants
n=129 Participants
|
34 Participants
n=257 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=128 Participants
|
129 participants
n=129 Participants
|
257 participants
n=257 Participants
|
|
Number of Participants who received intravenous tissue-type plasminogen activator treatment
|
78 Participants
n=128 Participants
|
72 Participants
n=129 Participants
|
150 Participants
n=257 Participants
|
|
Number of Participants with Atrial Flutter/Atrial Fibrillation
|
23 Participants
n=128 Participants
|
32 Participants
n=129 Participants
|
55 Participants
n=257 Participants
|
|
Number of Participants with a history of diabetes
|
26 Participants
n=128 Participants
|
34 Participants
n=129 Participants
|
60 Participants
n=257 Participants
|
|
Number of Participants with a History of Hypertension
|
77 Participants
n=128 Participants
|
95 Participants
n=129 Participants
|
172 Participants
n=257 Participants
|
|
Number of Participants with a History of Stroke
|
19 Participants
n=128 Participants
|
24 Participants
n=129 Participants
|
43 Participants
n=257 Participants
|
|
Number of Participants with Coronary artery disease
|
9 Participants
n=128 Participants
|
17 Participants
n=129 Participants
|
26 Participants
n=257 Participants
|
|
Number of Participants with Peripheral Vascular Disease
|
1 Participants
n=128 Participants
|
4 Participants
n=129 Participants
|
5 Participants
n=257 Participants
|
|
Number of participants with prior use of antiplatelets
|
26 Participants
n=128 Participants
|
36 Participants
n=129 Participants
|
62 Participants
n=257 Participants
|
|
Number of participants with prior use of anticoagulants
|
15 Participants
n=128 Participants
|
30 Participants
n=129 Participants
|
45 Participants
n=257 Participants
|
|
Vessels Occluded
middle cerebral artery (MCA)- M1
|
77 Participants
n=128 Participants
|
69 Participants
n=129 Participants
|
146 Participants
n=257 Participants
|
|
Vessels Occluded
middle cerebral artery (MCA)- M2 Proximal
|
30 Participants
n=128 Participants
|
33 Participants
n=129 Participants
|
63 Participants
n=257 Participants
|
|
Vessels Occluded
anterior cerebral artery (ACA)- A1
|
1 Participants
n=128 Participants
|
2 Participants
n=129 Participants
|
3 Participants
n=257 Participants
|
|
Vessels Occluded
anterior cerebral artery (ACA)- A2 Proximal
|
1 Participants
n=128 Participants
|
1 Participants
n=129 Participants
|
2 Participants
n=257 Participants
|
|
Vessels Occluded
No Vessels Occluded
|
6 Participants
n=128 Participants
|
9 Participants
n=129 Participants
|
15 Participants
n=257 Participants
|
|
Vessels Occluded
Unknown
|
2 Participants
n=128 Participants
|
4 Participants
n=129 Participants
|
6 Participants
n=257 Participants
|
|
Vessels Occluded
Internal Carotid Artery (ICA) Terminus
|
26 Participants
n=128 Participants
|
22 Participants
n=129 Participants
|
48 Participants
n=257 Participants
|
|
Time from Stroke Onset to Endovascular Therapy
less than 6 hours
|
88 Participants
n=128 Participants
|
89 Participants
n=129 Participants
|
177 Participants
n=257 Participants
|
|
Time from Stroke Onset to Endovascular Therapy
6 hours to 16 hours
|
40 Participants
n=128 Participants
|
40 Participants
n=129 Participants
|
80 Participants
n=257 Participants
|
|
Pre-stroke mRS
0
|
102 Participants
n=128 Participants
|
105 Participants
n=129 Participants
|
207 Participants
n=257 Participants
|
|
Pre-stroke mRS
1
|
14 Participants
n=128 Participants
|
12 Participants
n=129 Participants
|
26 Participants
n=257 Participants
|
|
Pre-stroke mRS
2
|
12 Participants
n=128 Participants
|
12 Participants
n=129 Participants
|
24 Participants
n=257 Participants
|
|
Time from Stroke onset to Groin puncture
|
488 minutes
n=72 Participants • Data were not collected from 56 participants in the general anesthesia arm and 65 participants in the sedation arm because the stroke onset was not witnessed, therefore the stroke onset time could not be collected.
|
508 minutes
n=64 Participants • Data were not collected from 56 participants in the general anesthesia arm and 65 participants in the sedation arm because the stroke onset was not witnessed, therefore the stroke onset time could not be collected.
|
495 minutes
n=136 Participants • Data were not collected from 56 participants in the general anesthesia arm and 65 participants in the sedation arm because the stroke onset was not witnessed, therefore the stroke onset time could not be collected.
|
|
Time from Door to Groin puncture
|
78 minutes
n=122 Participants • Data were not collected from 6 participants in the general anesthesia arm because 3 were in-hospital patients, so door time can not be collected, and 3 participants did not receive Endovascular thrombectomy (EVT) procedure, so groin puncture time can not be collected. Data were not collected from 7 participants in the sedation arm because 3 were in-hospital patients, so door time can not be collected, and 4 did not undergo EVT procedure so, groin puncture time can not be collected.
|
69 minutes
n=122 Participants • Data were not collected from 6 participants in the general anesthesia arm because 3 were in-hospital patients, so door time can not be collected, and 3 participants did not receive Endovascular thrombectomy (EVT) procedure, so groin puncture time can not be collected. Data were not collected from 7 participants in the sedation arm because 3 were in-hospital patients, so door time can not be collected, and 4 did not undergo EVT procedure so, groin puncture time can not be collected.
|
71 minutes
n=244 Participants • Data were not collected from 6 participants in the general anesthesia arm because 3 were in-hospital patients, so door time can not be collected, and 3 participants did not receive Endovascular thrombectomy (EVT) procedure, so groin puncture time can not be collected. Data were not collected from 7 participants in the sedation arm because 3 were in-hospital patients, so door time can not be collected, and 4 did not undergo EVT procedure so, groin puncture time can not be collected.
|
|
Time from Angiosuite to Groin puncture
|
17 minutes
n=125 Participants • Data were not collected from 3 participants in the general anesthesia arm because 3 participants did not receive Endovascular thrombectomy (EVT) procedure, so groin puncture time can not be collected. Data were not collected from 4 participants in the sedation arm because 4 participants did not undergo EVT procedure so, groin puncture time could not be collected.
|
12 minutes
n=125 Participants • Data were not collected from 3 participants in the general anesthesia arm because 3 participants did not receive Endovascular thrombectomy (EVT) procedure, so groin puncture time can not be collected. Data were not collected from 4 participants in the sedation arm because 4 participants did not undergo EVT procedure so, groin puncture time could not be collected.
|
15 minutes
n=250 Participants • Data were not collected from 3 participants in the general anesthesia arm because 3 participants did not receive Endovascular thrombectomy (EVT) procedure, so groin puncture time can not be collected. Data were not collected from 4 participants in the sedation arm because 4 participants did not undergo EVT procedure so, groin puncture time could not be collected.
|
|
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
|
15 score on a scale
n=128 Participants
|
16 score on a scale
n=129 Participants
|
15 score on a scale
n=257 Participants
|
|
Alberta Stroke Program Early CT Score
|
8 score on a scale
n=125 Participants • Data were not collected from 3 participants in the general anesthesia arm and 1 participant in the sedation arm because CT imaging was not performed, therefore an ASPECT score could not be captured,
|
9 score on a scale
n=128 Participants • Data were not collected from 3 participants in the general anesthesia arm and 1 participant in the sedation arm because CT imaging was not performed, therefore an ASPECT score could not be captured,
|
9 score on a scale
n=253 Participants • Data were not collected from 3 participants in the general anesthesia arm and 1 participant in the sedation arm because CT imaging was not performed, therefore an ASPECT score could not be captured,
|
PRIMARY outcome
Timeframe: 90 daysmRS 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
Outcome measures
| Measure |
General Anesthesia
n=120 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=120 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Modified Ordinal Rankin Scale (mRS)
score of 0
|
16 Participants
|
11 Participants
|
|
Modified Ordinal Rankin Scale (mRS)
score of 1
|
21 Participants
|
23 Participants
|
|
Modified Ordinal Rankin Scale (mRS)
score of 2
|
20 Participants
|
13 Participants
|
|
Modified Ordinal Rankin Scale (mRS)
score of 3
|
21 Participants
|
24 Participants
|
|
Modified Ordinal Rankin Scale (mRS)
score of 4
|
9 Participants
|
16 Participants
|
|
Modified Ordinal Rankin Scale (mRS)
score of 5 or 6
|
33 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
General Anesthesia
n=120 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=120 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Dichotomized Modified Ordinal Rankin Scale (mRS)
Score of 0, 1, or 2
|
57 Participants
|
47 Participants
|
|
Dichotomized Modified Ordinal Rankin Scale (mRS)
Score of 3, 4, 5, or 6
|
63 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: post procedure within 6 hoursPopulation: Data were not collected from 6 participants in the general anesthesia arm and 7 participants in the sedation arm because they did not undergo the angiogram procedure.
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
Outcome measures
| Measure |
General Anesthesia
n=122 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=122 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b
|
118 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 24-36 hours post procedurePopulation: Data were not collected for 8 participants in the General Anesthesia arm and 5 participants in the Sedation arm because the National Institutes of Health Stroke Scale (NIHSS) assessment was not performed for these participants.
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
Outcome measures
| Measure |
General Anesthesia
n=120 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=124 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
|
7 score on a scale
Interval 3.0 to 14.0
|
6 score on a scale
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: 90 daysThe 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
Outcome measures
| Measure |
General Anesthesia
n=120 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=120 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2
|
57 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Data were not collected from 16 participants in the general anesthesia arm and Data were not collected from 14 participants in the Sedation arm because the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) assessment was not administered to these participants.
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.
Outcome measures
| Measure |
General Anesthesia
n=112 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=115 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment
|
0.47 score on a scale
Standard Deviation 0.44
|
0.46 score on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: 18-36 hours post procedurePopulation: Data were not collected from 3 participants in the general anesthesia arm and Data were not collected from 4 participants in the Sedation arm because these participants did not undergo imaging at this timeframe therefore the data were not available for them.
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.
Outcome measures
| Measure |
General Anesthesia
n=125 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=125 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Number of Participants With Symptomatic Intracerebral Hemorrhage
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 18-36 hours post procedureOutcome measures
| Measure |
General Anesthesia
n=128 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=129 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Number of Participants With All-cause Mortality
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 18-36 hours post procedurePopulation: Data were not collected from 2 participants in the General Anesthesia arm and Data were not collected from 4 participants in the Sedation arm because the angiogram procedure was not performed.
Outcome measures
| Measure |
General Anesthesia
n=126 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=125 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Number of Participants With Procedural Complications
|
4 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: post procedure within 6 hoursPopulation: Data were not collected from 4 participants in the general anesthesia arm and 4 participants in the sedation arm because they did not undergo the EVT procedure.
Outcome measures
| Measure |
General Anesthesia
n=124 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=125 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Time From Groin Puncture to Reperfusion
|
41 minutes
Interval 25.0 to 66.0
|
43 minutes
Interval 29.0 to 65.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: post procedure within 6 hoursPopulation: Data were not collected from 6 participants in the General Anesthesia arm and 6 participants in the Sedation arm because they did not have the EVT procedure.
Outcome measures
| Measure |
General Anesthesia
n=122 Participants
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=123 Participants
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Time From Door to TICI ≥ 2b Reperfusion
|
121 minutes
Interval 90.0 to 149.0
|
116 minutes
Interval 93.0 to 138.0
|
Adverse Events
General Anesthesia
Serious events: 62 serious events
Other events: 0 other events
Deaths: 11 deaths
Sedation
Serious events: 65 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
General Anesthesia
n=130 participants at risk
General Anesthesia (GA): The protocol doesn't specify a particular combination of 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)
Intra-arterial Thrombectomy: 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.
|
Sedation
n=130 participants at risk
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.
Sedation: 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.
Intra-arterial Thrombectomy: 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.
|
|---|---|---|
|
Vascular disorders
intracerebral hemorrhage asymptomatic
|
45.4%
59/130 • from baseline to 90 days after discharge
|
45.4%
59/130 • from baseline to 90 days after discharge
|
|
Vascular disorders
intracerebral hemorrhage symptomatic
|
0.77%
1/130 • from baseline to 90 days after discharge
|
2.3%
3/130 • from baseline to 90 days after discharge
|
|
Surgical and medical procedures
Procedure Complications
|
3.1%
4/130 • from baseline to 90 days after discharge
|
3.8%
5/130 • from baseline to 90 days after discharge
|
Other adverse events
Adverse event data not reported
Additional Information
Peng Roc Chen, MD
The University of Texas Health Science Center at Houston
Phone: 713-486-8016
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place