Trial Outcomes & Findings for Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy (NCT NCT01769586)

Results Overview

Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. This scale ranges from 0 to 5, where 0 denotes general anesthesia, in which the patient has no response to painful stimuli, and 5 denotes a level of minimal sedation in which the patient is fully awake.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

Approximately 10 minutes or less

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Diphenhydramine Increments of 25 mcg to maximum of 3 times (total 75 mcg) Diphenhydramine	Midazolam 1.5 mg increments up to 3 times (maximum 4.5 mg) Midazolam
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diphenhydramine n=100 Participants Increments of 25 mcg to maximum of 3 times (total 75 mcg) Diphenhydramine	Midazolam n=100 Participants 1.5 mg increments up to 3 times (maximum 4.5 mg) Midazolam	Total n=200 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	61 years n=7 Participants	60 years n=5 Participants
Gender Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Gender Male	94 Participants n=5 Participants	93 Participants n=7 Participants	187 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 10 minutes or less

Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. This scale ranges from 0 to 5, where 0 denotes general anesthesia, in which the patient has no response to painful stimuli, and 5 denotes a level of minimal sedation in which the patient is fully awake.

Outcome measures

Outcome measures
Measure	Diphenhydramine n=100 Participants Increments of 25 mcg to maximum of 3 times (total 75 mcg) Diphenhydramine	Midazolam n=100 Participants 1.5 mg increments up to 3 times (maximum 4.5 mg) Midazolam
Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)	27 participants	65 participants

Adverse Events

Diphenhydramine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diphenhydramine n=100 participants at risk Increments of 25 mcg to maximum of 3 times (total 75 mcg) Diphenhydramine	Midazolam n=100 participants at risk 1.5 mg increments up to 3 times (maximum 4.5 mg) Midazolam
General disorders Desaturation	1.0% 1/100	2.0% 2/100
General disorders Hypotension	1.0% 1/100	6.0% 6/100

Additional Information

Dr. Loren Laine

VA Connecticut Healthcare System

Phone: 203-932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place