Trial Outcomes & Findings for Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma (NCT NCT02439164)
NCT ID: NCT02439164
Last Updated: 2017-08-25
Results Overview
this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
after sedation
Results posted on
2017-08-25
Participant Flow
Participant milestones
| Measure |
Glioma Group
Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Non-neurosurgical Group
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma
Baseline characteristics by cohort
| Measure |
Glioma Group
n=15 Participants
Patients in this group will be administered sedatives (midazolam or propofol or dexmedetomidine) titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Non-neurosurgical Group
n=17 Participants
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years old
STANDARD_DEVIATION 9 • n=5 Participants
|
35 years old
STANDARD_DEVIATION 7 • n=7 Participants
|
40 years old
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
weight
|
64.9 kg
STANDARD_DEVIATION 14.0 • n=5 Participants
|
75.8 kg
STANDARD_DEVIATION 5.1 • n=7 Participants
|
70.7 kg
STANDARD_DEVIATION 21.1 • n=5 Participants
|
|
education
primary school
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
education
middle school
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
education
high school
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
education
college
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after sedationthis is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.
Outcome measures
| Measure |
Glioma Group
n=15 Participants
Patients in this group will be administered sedative midazolam titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Non-neurosurgical Group
n=17 Participants
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
|---|---|---|
|
Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test
baseline for ipsilesional hand
|
21.8 seconds
Standard Deviation 7.1
|
19.1 seconds
Standard Deviation 3.2
|
|
Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test
after sedation for ipsilesional hand
|
35.5 seconds
Standard Deviation 16.6
|
21.4 seconds
Standard Deviation 3.41
|
|
Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test
baseline for contralesional hand
|
27.8 seconds
Standard Deviation 15.9
|
19.1 seconds
Standard Deviation 3.2
|
|
Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test
after sedation for contralesional hand
|
54.3 seconds
Standard Deviation 32.4
|
21.4 seconds
Standard Deviation 3.41
|
SECONDARY outcome
Timeframe: withing 1 hourOAA/S is Observer Assessment of Sedation with 5 levels (5 = alert, 4 = lethargic, 3 = aroused by voice, 2 = aroused by shaking, 1 = deep sleep), all participants have to achieve OAA/S=4 after sedation.
Outcome measures
| Measure |
Glioma Group
n=15 Participants
Patients in this group will be administered sedative midazolam titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Non-neurosurgical Group
n=17 Participants
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
|---|---|---|
|
Number of Participants With OAA/S=4 After Sedation
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 1 hourThe MAP was measured at three time points: baseline, sedation and sedation reversal.
Outcome measures
| Measure |
Glioma Group
n=15 Participants
Patients in this group will be administered sedative midazolam titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Non-neurosurgical Group
n=17 Participants
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
|---|---|---|
|
Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change
baseline MAP
|
96.5 mmHg
Standard Deviation 13.5
|
95.7 mmHg
Standard Deviation 14.7
|
|
Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change
sedation MAP
|
96.2 mmHg
Standard Deviation 9.5
|
91.2 mmHg
Standard Deviation 12.2
|
|
Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change
sedation reversal MAP
|
95.4 mmHg
Standard Deviation 13.6
|
88.2 mmHg
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 1 hourThe HR was measured at three time points: baseline, sedation and sedation reversal.
Outcome measures
| Measure |
Glioma Group
n=15 Participants
Patients in this group will be administered sedative midazolam titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Non-neurosurgical Group
n=17 Participants
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
|---|---|---|
|
Heart Rate as a Measure of Physiological Change
baseline
|
78.1 bpm
Standard Deviation 15.6
|
79.0 bpm
Standard Deviation 9.1
|
|
Heart Rate as a Measure of Physiological Change
sedation
|
84.3 bpm
Standard Deviation 14.3
|
79.0 bpm
Standard Deviation 9.4
|
|
Heart Rate as a Measure of Physiological Change
sedation reversal
|
81.5 bpm
Standard Deviation 17.7
|
71.5 bpm
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: In non-neurosurgical group, patients were not diagnosed as glioma, so the belowed "outcome measure data table" could not indicate the number of glioma grade.
the WHO grade and the type of glioma (WHO glioma grade I\~II is regarded as low grade glioma, WHO glioma grade III\~IV is regarded as high grade glioma)
Outcome measures
| Measure |
Glioma Group
n=15 Participants
Patients in this group will be administered sedative midazolam titrating to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
Non-neurosurgical Group
patients in this group will be administered the same sedative midazolam as compared glioma group, and titrate to mild sedation.
Midazolam: specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used as a reversal
|
|---|---|---|
|
Brain Glioma Pathological Diagnose as a Measure of Tumor Type
low grade glioma
|
6 Participants
|
—
|
|
Brain Glioma Pathological Diagnose as a Measure of Tumor Type
high grade glioma
|
9 Participants
|
—
|
Adverse Events
Glioma Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-neurosurgical Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place