Effect of Benadryl Sedation During ERCP or EUS - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

July 8, 2008

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Recovery score

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00240123 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of sedation

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Benadryl Sedation During ERCP or EUS

Official Title ^ICMJE

Effect of Diphenhydramine Sedation During Endoscopic Retrograde Cholangio-Pancreatography (ERCP) or Endoscopic Ultrasound (EUS)

Brief Summary

The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.

Detailed Description

The usual sedatives used for endoscopy are meperidine (Demerol) and midazolam (Versed). Benadryl (Diphenhydramine) is often used in addition to these medications in an effort to improve sedation. There is little published information regarding the use of diphenhydramine in conscious sedation. It is recognized that certain patients have features that predict difficult sedation such as prescription sedative use or heavy alcohol use. In addition, prolonged procedures like ERCP and EUS require higher doses of sedatives. Diphenhydramine may improve the quality of sedation in patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP) or endoscopic ultrasound (EUS) procedures. You are being asked to participate because you are already scheduled to undergo one of these procedures.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Gallbladder Disease
Gallstones
Pancreatitis
Abdominal Pain
Jaundice

Intervention ^ICMJE

Drug: Benadryl versus Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

100

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients between 18 and 65 years of age who present for outpatient ERCP or EUS at Strong Memorial Hospital Endoscopy Center will be included

Exclusion Criteria:

Allergy to diphenhydramine, narrow angle glaucoma, or inability to consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00240123

Responsible Party

Study ID Numbers ^ICMJE

10454

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Benedict Maliakkal, MD

University of Rochester Medical Center, Digestive and Liver Disease Unit

Information Provided By

University of Rochester

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP