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Effect of Benadryl Sedation During ERCP or EUS

Primary Purpose

Gallbladder Disease, Gallstones, Pancreatitis

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Benadryl versus Placebo

About this trial

This is an interventional diagnostic trial for Gallbladder Disease focused on measuring ERCP, EUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Recovery score

Secondary Outcome Measures

Quality of sedation

Full Information

NCT ID

NCT00240123

First Posted

September 13, 2005

Last Updated

September 16, 2015

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT00240123

Brief Title

Effect of Benadryl Sedation During ERCP or EUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Withdrawn

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Rochester

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gallbladder Disease, Gallstones, Pancreatitis, Abdominal Pain, Jaundice

Keywords

ERCP, EUS

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Benadryl versus Placebo

Primary Outcome Measure Information:

Title

Recovery score

Secondary Outcome Measure Information:

Title

Quality of sedation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benedict Maliakkal, MD

Organizational Affiliation

University of Rochester Medical Center, Digestive and Liver Disease Unit

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Effect of Benadryl Sedation During ERCP or EUS

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