Trial Outcomes & Findings for The Effect of Intravenous Anesthetics on Fear Learning and Memory (NCT NCT00767767)
NCT ID: NCT00767767
Last Updated: 2019-05-15
Results Overview
Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
First Trial, for up to 1 day
Results posted on
2019-05-15
Participant Flow
Participant milestones
| Measure |
Placebos
Saline Infusion
Placebos: IV Saline infusion for 2 hours.
|
Propofol 0.45mcg/mL
Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours.
|
Propofol 0.9mcg/mL
Anesthetic Drug Infusion
Propofol 0.9mcg/mL: IV Propofol infusion for 2 hours.
|
Thiopental 1.5mcg/mL
Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours.
|
Thiopental 3mcg/mL
Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
20
|
3
|
3
|
|
Overall Study
COMPLETED
|
21
|
20
|
20
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Intravenous Anesthetics on Fear Learning and Memory
Baseline characteristics by cohort
| Measure |
Placebos
n=21 Participants
Saline Infusion
Placebos: IV Saline infusion for 2 hours.
|
Propofol 0.45mcg/mL
n=20 Participants
Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours.
|
Propofol 0.9mcg/mL
n=20 Participants
Anesthetic Drug Infusion
Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours.
|
Thiopental 1.5mcg/mL
n=3 Participants
Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours.
|
Thiopental 3mcg/mL
n=3 Participants
Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.1 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
25.4 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
25.6 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
23.7 years
STANDARD_DEVIATION 3.4 • n=4 Participants
|
26.3 years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
25.2 years
STANDARD_DEVIATION 4.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: First Trial, for up to 1 dayGalvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)
Outcome measures
| Measure |
Placebos
n=21 Participants
Saline Infusion
Placebos: IV Saline infusion for 2 hours.
|
Propofol 0.45mcg/mL
n=20 Participants
Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours.
|
Propofol 0.9mcg/mL
n=20 Participants
Anesthetic Drug Infusion
Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours.
|
Thiopental 1.5mcg/mL
n=3 Participants
Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours.
|
Thiopental 3mcg/mL
n=3 Participants
Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours.
|
|---|---|---|---|---|---|
|
GSR Trial 1
|
.62 units on a scale
Standard Deviation .50
|
.55 units on a scale
Standard Deviation .51
|
.55 units on a scale
Standard Deviation .51
|
.67 units on a scale
Standard Deviation .5
|
0 units on a scale
Standard Deviation 0
|
Adverse Events
Placebos
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol 0.45mcg/mL
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Propofol 0.90mcg/mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thiopental 1.5mcg/mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thiopental 3mcg/mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebos
n=21 participants at risk
Saline Infusion
Placebos: IV Saline infusion for 2 hours.
|
Propofol 0.45mcg/mL
n=20 participants at risk
Anesthetic Drug Infusion
Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours.
|
Propofol 0.90mcg/mL
n=20 participants at risk
Anesthetic Drug Infusion
Propofol 0.90mcg/mL: IV Propofol infusion for 2 hours.
|
Thiopental 1.5mcg/mL
n=3 participants at risk
Anesthetic Drug Infusion
Thiopental 1.5mcg/mL: IV Thiopental 1.5mcg/mL infusion for 2 hours
|
Thiopental 3mcg/mL
n=3 participants at risk
Anesthetic Drug Infusion
Thiopental 3mcg/mL: IV Thiopental 3mcg/mL infusion for 2 hours
|
|---|---|---|---|---|---|
|
General disorders
Extreme Fidgety
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
0.00%
0/3
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place