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

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

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 day

Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)

Outcome measures

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

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

Kane Pryor

Weill Cornell Medicine

Phone: (212) 746-2969

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place