Trial Outcomes & Findings for Neuroimaging of Anesthetic Modulation of Human Consciousness (NCT NCT03361605)

NCT ID: NCT03361605

Last Updated: 2020-08-18

Results Overview

Change = BOLD Response During Sedation - BOLD Response During Baseline

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline to 90 minutes
• Results posted on: 2020-08-18

Participant Flow

Participant milestones

Measure	Propofol Administration Propofol: Propofol administration
Overall Study STARTED	29
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Propofol Administration Propofol: Propofol administration
Overall Study Analyzable data not available	3

Baseline Characteristics

Analyzable data was not available for four subjects

Baseline characteristics by cohort

Measure	Propofol Administration n=29 Participants Propofol: Propofol administration
Age, Categorical <=18 years	0 Participants n=29 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=29 Participants
Age, Categorical >=65 years	0 Participants n=29 Participants
Sex: Female, Male Female	15 Participants n=29 Participants
Sex: Female, Male Male	14 Participants n=29 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=29 Participants
Race (NIH/OMB) Asian	7 Participants n=29 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=29 Participants
Race (NIH/OMB) Black or African American	2 Participants n=29 Participants
Race (NIH/OMB) White	18 Participants n=29 Participants
Race (NIH/OMB) More than one race	0 Participants n=29 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=29 Participants
BOLD response	0.599 percentage of BOLD signal change STANDARD_DEVIATION 0.244 • n=26 Participants • Analyzable data was not available for four subjects
Squeeze pressure	13.98 mmHg STANDARD_DEVIATION 5.27 • n=26 Participants • Analyzable data was not available for four subjects

PRIMARY outcome

Timeframe: Baseline to 90 minutes

Population: Intent to study brain activity change (BOLD response) during propofol administration

Change = BOLD Response During Sedation - BOLD Response During Baseline

Outcome measures

Measure	Propofol Administration n=26 Participants Propofol: Propofol administration
Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation	-0.349 percentage of BOLD signal change Standard Deviation 0.223

SECONDARY outcome

Timeframe: Baseline to 90 minutes

Population: Intent to study squeeze pressure change during propofol administration

Measurements of the force of participants' hand squeezing on a rubber ball in response to instructions. Change = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline.

Outcome measures

Measure	Propofol Administration n=26 Participants Propofol: Propofol administration
Change From Baseline in Squeeze Pressure	-2.16 Millimeter of mercury (mmHg) Standard Deviation 3.09

Adverse Events

Propofol Administration

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

Amy McKinney

University of Michigan

Phone: 734-647-8129

Email: adrongo@med.umich.edu

Results disclosure agreements

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