Endoscopy, Sedation
Conditions
Keywords
Sedation, Endoscopy, Diphenhydramine, Midazolam
Brief summary
Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.
Detailed description
Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine (up to 3 incremental doses of 25 mcg each) vs. continued midazolam (up to 3 incremental doses of 1.5 mg each). the level of sedation will be assessed using the MOAA/S scale 2-3 minutes after each administration to determine if they are sufficiently sedated to begin colonoscopy. The patient, the healthcare team involved in performing the endoscopy, and the investigator assessing sedation will be blinded to the therapy. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.
Interventions
DRUGDiphenhydramine
DRUGMidazolam
Sponsors
VA Connecticut Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>18 years-old who are undergoing elective colonoscopy with conscious sedation
Exclusion criteria
* allergy or prior adverse reactions to diphenhydramine * medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma) * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diphenhydramine Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Diphenhydramine | 100 |
| Midazolam 1.5 mg increments up to 3 times (maximum 4.5 mg)
Midazolam | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Diphenhydramine | Midazolam | Total |
|---|---|---|---|
| Age, Continuous | 60 years | 61 years | 60 years |
| Gender Female | 6 Participants | 7 Participants | 13 Participants |
| Gender Male | 94 Participants | 93 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 100 | 8 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)
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.
Time frame: Approximately 10 minutes or less
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diphenhydramine | Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3) | 27 participants |
| Midazolam | Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3) | 65 participants |
p-value: <0.00195% CI: [0.24, 0.5]Chi-squared