Trial Outcomes & Findings for Memory Modulation by Pain During Anesthesia (NCT NCT02515890)

Last Updated: 2020-07-01

Results Overview

Subjects completed the Remember, Know, New (RKN) task during next day testing. Their d' memory score was calculated based on their ability to discriminate between previously heard words and new words. A higher d' score indicates stronger recollection. D' scores were compared across the control condition (saline) and the drug conditions dexmedetomidine, midazolam, and ketamine. Performance was also calculated according to words associated with Pain and No Pain conditions.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

At memory testing 1 day later

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine subjects received dexmedetomidine and saline (control)	Midazolam subjects received midazolam and saline (control)	Ketamine subjects received ketamine and saline (control)	Drug Order A Subjects received saline (control) and midazolam during their first set of experimental sessions, and then received saline (control) and ketamine during a second set of sessions	Drug Order B Subjects received saline (control) and ketamine during their first set of experimental sessions, and then received saline (control) and midazolam during a second set of sessions
Overall Study STARTED	7	4	5	8	8
Overall Study COMPLETED	7	4	5	8	8
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine Only n=7 Participants All subjects received saline (control) followed by dexmedetomidine infusion while performing memory task and receiving intermittent painful electric nerve stimulation.	Midazolam Only n=4 Participants All subjects received saline (control) followed by midazolam infusion while performing memory task and receiving intermittent painful electric nerve stimulation.	Ketamine Only n=5 Participants All subjects received saline (control) followed by ketamine infusion while performing memory task and receiving intermittent painful electric nerve stimulation.	Drug Order A n=8 Participants All subjects received saline (control) followed by midazolam infusion while performing memory task and receiving intermittent painful electric nerve stimulation on their first experimental visit. For another experimental session, all subjects received saline (control) followed by ketamine infusion while performing memory task and receiving intermittent painful electric nerve stimulation.	Drug Order B n=8 Participants All subjects received saline (control) followed by ketamine infusion while performing memory task and receiving intermittent painful electric nerve stimulation on their first experimental visit. For another experimental session, all subjects received saline (control) followed by midazolam infusion while performing memory task and receiving intermittent painful electric nerve stimulation.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants	4 Participants n=4 Participants	5 Participants n=5 Participants	8 Participants n=8 Participants	8 Participants n=8 Participants	32 Participants n=32 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=5 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	2 Participants n=4 Participants	1 Participants n=5 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	14 Participants n=32 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	2 Participants n=4 Participants	4 Participants n=5 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	18 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	4 participants n=4 Participants	5 participants n=5 Participants	8 participants n=8 Participants	8 participants n=8 Participants	32 participants n=32 Participants

PRIMARY outcome

Timeframe: At memory testing 1 day later

Population: The overall number analyzed for each drug condition represents the number of observations for that drug, which doesn't directly correspond to study arms. All participants received a saline control condition with their drug condition. Therefore, there were 48 saline observations (saline d' scores) which includes observations from all 5 study arms.