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

Study Overview
=================
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.

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

Conditions
-----------------
Sedation, Endoscopy

Intervention / Treatment
-----------------
* Drug: Diphenhydramine
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diphenhydramine<br>Increments of 25 mcg to maximum of 3 times (total 75 mcg) | Drug: Diphenhydramine<br> <br> |
| Active Comparator: Midazolam<br>1.5 mg increments up to 3 times (maximum 4.5 mg) | Drug: Midazolam<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Approximately 10 minutes or less | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, Endoscopy, Diphenhydramine, Midazolam