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Trial record 27 of 39 for:    FLUMAZENIL

Sedatives' Effects on Neurological Function in Patients With Eloquent Area Glioma

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ClinicalTrials.gov Identifier: NCT02439164
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Nan Lin, Beijing Tiantan Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Other
Condition Glioma
Intervention Drug: Midazolam
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glioma Group Non-neurosurgical Group
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Glioma Group Non-neurosurgical Group Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 15 17 32
Hide Baseline Analysis Population Description
One patient in non-neurosurgical group was dropped out because he reported his carotid disease history after the task testing. In glioma group, pathological diagnosis displayed two with metastasis and one with meningioma, which were excluded during follow-up. There are 15 in the glioma group and 17 in the control group for the analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years old
Number Analyzed 15 participants 17 participants 32 participants
46  (9) 35  (7) 40  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
Female
8
  53.3%
10
  58.8%
18
  56.3%
Male
7
  46.7%
7
  41.2%
14
  43.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
15
 100.0%
17
 100.0%
32
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 15 participants 17 participants 32 participants
15 17 32
weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 15 participants 17 participants 32 participants
64.9  (14.0) 75.8  (5.1) 70.7  (21.1)
education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 32 participants
primary school
2
  13.3%
3
  17.6%
5
  15.6%
middle school
2
  13.3%
2
  11.8%
4
  12.5%
high school
8
  53.3%
2
  11.8%
10
  31.3%
college
3
  20.0%
10
  58.8%
13
  40.6%
1.Primary Outcome
Title Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test
Hide Description this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.
Time Frame after sedation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioma Group Non-neurosurgical Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 17
Mean (Standard Deviation)
Unit of Measure: seconds
baseline for contralesional hand 27.8  (15.9) 19.1  (3.2)
after sedation for contralesional hand 54.3  (32.4) 21.4  (3.41)
baseline for ipsilesional hand 21.8  (7.1) 19.1  (3.2)
after sedation for ipsilesional hand 35.5  (16.6) 21.4  (3.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glioma Group, Non-neurosurgical Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments bonferroni correction was used for post hoc analysis, P value less than 0.05 indicated statistical significance.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 23.51
Confidence Interval (2-Sided) 95%
14.16 to 32.87
Estimation Comments this described the difference during midazolam sedation between the glioma and control group without dividing into subgroups.
Other Statistical Analysis Oneway Analysis of Variance (ANOVA) was used to test the difference among hands in a certain time point. General linear model for repeated measures ANOVA was used to analyze the time difference of test before and after drug administration,
2.Secondary Outcome
Title Number of Participants With OAA/S=4 After Sedation
Hide Description OAA/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.
Time Frame withing 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioma Group Non-neurosurgical Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 17
Measure Type: Count of Participants
Unit of Measure: Participants
15
 100.0%
17
 100.0%
3.Secondary Outcome
Title Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change
Hide Description The MAP was measured at three time points: baseline, sedation and sedation reversal.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioma Group Non-neurosurgical Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 17
Mean (Standard Deviation)
Unit of Measure: mmHg
baseline MAP 96.5  (13.5) 95.7  (14.7)
sedation MAP 96.2  (9.5) 91.2  (12.2)
sedation reversal MAP 95.4  (13.6) 88.2  (14.1)
4.Secondary Outcome
Title Heart Rate as a Measure of Physiological Change
Hide Description The HR was measured at three time points: baseline, sedation and sedation reversal.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glioma Group Non-neurosurgical Group
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 15 17
Mean (Standard Deviation)
Unit of Measure: bpm
baseline 78.1  (15.6) 79.0  (9.1)
sedation 84.3  (14.3) 79.0  (9.4)
sedation reversal 81.5  (17.7) 71.5  (8.9)
5.Secondary Outcome
Title Brain Glioma Pathological Diagnose as a Measure of Tumor Type
Hide Description 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)
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glioma Group
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 15
Measure Type: Count of Participants
Unit of Measure: Participants
low grade glioma
6
  40.0%
high grade glioma
9
  60.0%
Time Frame 1 hour
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glioma Group Non-neurosurgical Group
Hide Arm/Group Description

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

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

All-Cause Mortality
Glioma Group Non-neurosurgical Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Glioma Group Non-neurosurgical Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glioma Group Non-neurosurgical Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Nan Lin
Organization: Beijing Tiantan Hospital
Phone: 861067096658
EMail: linnan127@163.com
Layout table for additonal information
Responsible Party: Nan Lin, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02439164     History of Changes
Other Study ID Numbers: 2014MP06
First Submitted: April 22, 2015
First Posted: May 8, 2015
Results First Submitted: June 30, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017