Propofol Versus Midazolam With Fentanyl for EGD Endomicro... | NCT01053871

Studies
Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

NCT01053871

Sponsor

Shandong University

Status

Completed

Last Update Posted

Jun 14, 2011Estimated

Enrollment

104Estimated

Phase

Not Applicable

Conditions

Gastritis
Functional Dyspepsia

Interventions

propofol
midazolam with fentanyl

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 21, 2010

First Submission Date that Met QC Criteria

Jan 21, 2010

First Posted Date

Jan 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2011

Last Update Posted Date

Jun 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	sedation using propofol	Drug: propofol
2	Experimental	sedation using midazolam with fentanyl	Drug: midazolam with fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol	Drug	conscious sedation using propofol	1
midazolam with fentanyl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
endomicroscopic image quality		3 months

Secondary Outcomes

Measure	Description	Time Frame
sedation efficacy outcomes,patient assessment,physician assessment		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

outpatients attending endomicroscopy
able to give written informed consent

Exclusion Criteria:

GI tract malignancy
coagulopathy
acute upper digestive tract bleeding
pregnancy or breast feeding
allergy to fluorescein sodium
impaired renal function

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yanqing Li, PhD. MD.	Department of Gastroenterology, Qilu Hospital, Shandong University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University		Jinan	Shandong		China

Condition Browse Module

MeSH Terms

ID	Term
D005756	Gastritis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D013272	Stomach Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D008874	Midazolam
D005283	Fentanyl

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided