Adjunct Sedatives in Procedures Involving Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of California, Irvine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of California, Irvine
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00937924
First received: June 4, 2008
Last updated: February 10, 2011
Last verified: February 2011
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Purpose
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.
| Condition | Intervention |
|---|---|
|
Endoscopic Ultrasound (EUS) Endoscopic Retrograde Cholangiopancreatography (ERCP) |
Drug: Saline Drug: Diphenhydramine Drug: Promethazine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine as Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) |
Resource links provided by NLM:
MedlinePlus related topics:
Endoscopy
Drug Information available for:
Promethazine hydrochloride
Diphenhydramine
Promethazine
Diphenhydramine hydrochloride
Diphenhydramine citrate
U.S. FDA Resources
Further study details as provided by University of California, Irvine:
Primary Outcome Measures:
- Sedation Level [ Time Frame: Pre-Endoscopic Procedure ] [ Designated as safety issue: Yes ]
- Time to achieve adequate level of sedation to begin procedure [ Time Frame: Pre-Endoscopic Procedure ] [ Designated as safety issue: Yes ]
- Time for Recovery [ Time Frame: Post-Endoscopic Procedure ] [ Designated as safety issue: Yes ]
- Adverse Symptoms From Sedative Agents [ Time Frame: Pre/post Endoscopic Procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 465 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Control. Normal Saline Injections.
|
Drug: Saline
Saline solution injections
|
|
Experimental: 2
Diphenhydramine injections given as adjunct sedative.
|
Drug: Diphenhydramine
Diphenhydramine injections
|
|
Experimental: 3
Promethazine given as an adjunct sedative.
|
Drug: Promethazine
Promethazine
|
Detailed Description:
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.
Exclusion Criteria:
- History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
- Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
- Patients with conditions that preclude safe conscious sedation will be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937924
Contacts
| Contact: Venkataraman Muthusamy, MD | 714 456-5765 | raman@uci.edu |
| Contact: Swapna Reddy, MD | sbreddy@uci.edu |
Locations
| United States, California | |
| H.H. Chao Comprehensive Digestive Disease Center | Recruiting |
| Orange, California, United States, 92868 | |
Sponsors and Collaborators
University of California, Irvine
More Information
No publications provided
| Responsible Party: | Dr. Venkataraman Muthusamy, Department of Gastroenterology |
| ClinicalTrials.gov Identifier: | NCT00937924 History of Changes |
| Other Study ID Numbers: | HS 2007-5810 |
| Study First Received: | June 4, 2008 |
| Last Updated: | February 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
EUS ERCP Sedation Level Adverse Symptoms Recovery time |
Additional relevant MeSH terms:
|
Diphenhydramine Promethazine Hypnotics and Sedatives 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 Central Nervous System Depressants Anti-Allergic Agents Anesthetics, Local Anesthetics Sensory System Agents Antipruritics Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013