The sedative effects and local tolerability of nasal administration of remimazolam using a Soft Mist Nasal Administration Device

Conditions

anxiety, stress anxiety

Brief summary

• Maximum decrease in Bispectral Index (BIS) value compared with baseline BIS.

Detailed description

• Changes in BIS signal over time., • Richmond Agitation Sedation Scale (RASS) score at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10, • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min., • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min., • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min.

Related papers

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Interventions

DRUGByfavo 20 mg powder for solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
• Maximum decrease in Bispectral Index (BIS) value compared with baseline BIS.	—

Secondary

Measure	Time frame
• Changes in BIS signal over time., • Richmond Agitation Sedation Scale (RASS) score at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10, • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min., • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min., • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min.	—

Measure

Time frame

• Changes in BIS signal over time., • Richmond Agitation Sedation Scale (RASS) score at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min. • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10, • Self-reported bipolar measure of alertness/drowsiness on a 0-100 VAS-scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min., • Self-reported bipolar measure of agitation/relaxation on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min., • Self-reported unipolar measure of perceived drug effects on a 0-100 VAS scale at baseline and T = 5, 10, 15, 20, 30, 40, 50, 60, 90, 180 min.

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Countries

Netherlands

Outcome results

None listed