Trial Outcomes & Findings for Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes (NCT NCT00504894)
NCT ID: NCT00504894
Last Updated: 2021-07-15
Results Overview
Three anatomical regions for which there was an a priori mechanistic hypothesis were assessed using standard small volume correction: (i) the amygdala, bilaterally; (ii) the hippocampus, bilaterally; and (iii) the parahippocampus, bilaterally. Using single-tailed t tests, a priori regions were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons in the hypothesized anatomical region. For non-hypothesized regions outside the medial temporal lobe, findings were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons across the whole brain. Clusters containing voxel maxima at these thresholds are reported.
TERMINATED
PHASE4
60 participants
for 90 minutes after the drug/placebo was commenced
2021-07-15
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
|
Propofol
Propofol give at 0.90 μgml-1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
Thiopental
Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.
Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
19
|
|
Overall Study
COMPLETED
|
17
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
|
Propofol
Propofol give at 0.90 μgml-1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
Thiopental
Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.
Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
|---|---|---|---|
|
Overall Study
fMRI technical problems
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Infusion technical problems
|
0
|
1
|
0
|
|
Overall Study
poor subject data
|
2
|
0
|
0
|
Baseline Characteristics
Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
|
Propofol
n=21 Participants
Propofol given at 0.90 μgml-1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
Thiopental
n=19 Participants
Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.
Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=99 Participants
|
25 years
n=107 Participants
|
24 years
n=206 Participants
|
25 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: for 90 minutes after the drug/placebo was commencedPopulation: Of the 20 placebo subjects recruited, 3 subjects' data was excluded due to technical problems or poor quality. Of the 21 propofol subjects recruited, 3 subjects' data was excluded due to technical problems, poor quality, or subject withdrawal. Of the 19 thiopental subjects recruited, no subjects' data was excluded.
Three anatomical regions for which there was an a priori mechanistic hypothesis were assessed using standard small volume correction: (i) the amygdala, bilaterally; (ii) the hippocampus, bilaterally; and (iii) the parahippocampus, bilaterally. Using single-tailed t tests, a priori regions were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons in the hypothesized anatomical region. For non-hypothesized regions outside the medial temporal lobe, findings were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons across the whole brain. Clusters containing voxel maxima at these thresholds are reported.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
|
Propofol
n=18 Participants
Propofol give at 0.90 μgml-1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
Thiopental
n=19 Participants
Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.
Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
|---|---|---|---|
|
Blood-oxygen-level-dependent Significant Activation Cluster
Right Hippocampus
|
1 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster
Left Hippocampus
|
1 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
1 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster
Right Parahippocampal Cortex
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster
Left Parahippocampal Cortex
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster
Right Amygdala
|
1 BOLD significantly activated clusters
|
1 BOLD significantly activated clusters
|
1 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster
Left Amygdala
|
1 BOLD significantly activated clusters
|
1 BOLD significantly activated clusters
|
1 BOLD significantly activated clusters
|
SECONDARY outcome
Timeframe: for 90 minutes after the drug/placebo was commencedPopulation: Of the 20 placebo subjects recruited, 3 subjects' data was excluded due to technical problems or poor quality. Of the 21 propofol subjects recruited, 3 subjects' data was excluded due to technical problems, poor quality, or subject withdrawal. Of the 19 thiopental subjects recruited, no subjects' data was excluded.
Three anatomical regions for which there was an a priori mechanistic hypothesis were assessed using standard small volume correction: (i) the amygdala, bilaterally; (ii) the hippocampus, bilaterally; and (iii) the parahippocampus, bilaterally. Using single-tailed t tests, a priori regions were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons in the hypothesized anatomical region. For non-hypothesized regions outside the medial temporal lobe, findings were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons across the whole brain. Clusters containing voxel maxima at these thresholds are reported.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo given in low dose to gauge subject's responses to visual stimuli.
Placebo: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.
|
Propofol
n=18 Participants
Propofol give at 0.90 μgml-1 to gauge subject's responses to visual stimuli.
Propofol: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
Thiopental
n=19 Participants
Thiopental give at 3.0 μgml-1 to gauge subject's responses to visual stimuli.
Thiopental: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.
|
|---|---|---|---|
|
Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory
Right Amygdala
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory
Left Amygdala
|
1 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory
Right Hippocampus
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
1 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory
Left Hippocampus
|
1 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory
Right Parahippocampal Cortex
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
|
Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory
Left Parahippocampal Cortex
|
0 BOLD significantly activated clusters
|
0 BOLD significantly activated clusters
|
1 BOLD significantly activated clusters
|
Adverse Events
Placebo
Propofol
Thiopental
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