Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Sedation Endoscopy |
Drug: Diphenhydramine Drug: Midazolam |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy |
- Proportion of patients who achieve adequate sedation to allow colonoscopy (defined as MOAA/S ≤3) [ Time Frame: Approximately 10 minutes or less ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Diphenhydramine
Increments of 25 mcg to maximum of 3 times (total 75 mcg)
|
Drug: Diphenhydramine |
|
Active Comparator: Midazolam
1.5 mg increments up to 3 times (maximum 4.5 mg)
|
Drug: Midazolam |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Loren Laine, MD | 203-937-3462 | loren.laine@yale.edu |
| United States, Connecticut | |
| VA Connecticut Healthcare System | Not yet recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Principal Investigator: Loren Laine, MD | |
| Principal Investigator: | Loren Laine, MD | VA Connecticut Healthcare System |
More Information
No publications provided
| Responsible Party: | VA Connecticut Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01769586 History of Changes |
| Other Study ID Numbers: | 0003 |
| Study First Received: | January 14, 2013 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by VA Connecticut Healthcare System:
|
Sedation Endoscopy Diphenhydramine Midazolam |
Additional relevant MeSH terms:
|
Diphenhydramine Promethazine Midazolam Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Central Nervous System Depressants Anti-Allergic Agents Anesthetics, Local Anesthetics Sensory System Agents Antipruritics Dermatologic Agents Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on May 19, 2013