Trial Outcomes & Findings for Implications of Anesthetics on Sleep Consolidation (NCT NCT04329091)

Last Updated: 2023-02-24

Results Overview

Subjects are tested in the morning for word recognition on hard-to-understand speech, then trained on this speech (never hearing the same words twice) which produces about 20 percentage points of improvement. After sedation subjects are re-tested. During the morning, afternoon and evening post-tests, subjects will be tested on new spoken words. At each time point where the perceptual learning protocol is administered the number of words correctly perceived out of 50 will be measured.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

1 day

Results posted on

2023-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine Arm Dexmedetomidine: Administration of a 0.5 mcg/kg bolus followed by an infusion of 0.5-0.7 mcg/kg/hr, titrated up by 0.1 mcg every 1 minute until the subject spontaneously closes his or her eyes. When the subject spontaneously closes his or her eyes the infusion continues for 90 minutes from that point. Dexmedetomidine: All subjects will receive Dexmedetomidine to induce sedation between their pre-sedation and post-sedation perceptual learning tests.
Overall Study STARTED	9
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexmedetomidine Arm Dexmedetomidine: Administration of a 0.5 mcg/kg bolus followed by an infusion of 0.5-0.7 mcg/kg/hr, titrated up by 0.1 mcg every 1 minute until the subject spontaneously closes his or her eyes. When the subject spontaneously closes his or her eyes the infusion continues for 90 minutes from that point. Dexmedetomidine: All subjects will receive Dexmedetomidine to induce sedation between their pre-sedation and post-sedation perceptual learning tests.
Overall Study Physician Decision	5

Baseline Characteristics

No data was collected or analyzed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine Arm n=9 Participants Dexmedetomidine: Administration of a 0.5 mcg/kg bolus followed by an infusion of 0.5-0.7 mcg/kg/hr, titrated up by 0.1 mcg every 1 minute until the subject spontaneously closes his or her eyes. When the subject spontaneously closes his or her eyes the infusion continues for 90 minutes from that point. Dexmedetomidine: All subjects will receive Dexmedetomidine to induce sedation between their pre-sedation and post-sedation perceptual learning tests.
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Sex: Female, Male Female	6 Participants n=9 Participants
Sex: Female, Male Male	3 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=9 Participants
Memory consolidation	0 Participants No data was collected or analyzed

PRIMARY outcome

Timeframe: 1 day

Population: Study terminated, no data was collected.

Outcome measures

Outcome data not reported

Adverse Events

Dexmedetomidine Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Al McAuley, Clinical Research Manager

UNIVERSITY OF CHICAGO

Phone: 7738343274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place