NCT01053871

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 14, 2011

Status Verified

December 1, 2009

Enrollment Period

4 months

First QC Date

January 21, 2010

Last Update Submit

June 13, 2011

Conditions

GastritisFunctional Dyspepsia

Keywords

normal

Outcome Measures

Primary Outcomes (1)

  • endomicroscopic image quality

    3 months

Secondary Outcomes (1)

  • sedation efficacy outcomes,patient assessment,physician assessment

    3 months

Study Arms (2)

1

EXPERIMENTAL

sedation using propofol

Drug: propofol

2

EXPERIMENTAL

sedation using midazolam with fentanyl

Drug: midazolam with fentanyl

Interventions

propofolDRUG

conscious sedation using propofol

1
midazolam with fentanylDRUG

conscious sedation using midazolam with fentanyl

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatients attending endomicroscopy
  • able to give written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Gastritis

Interventions

PropofolMidazolamFentanyl

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yanqing Li, PhD. MD.

    Department of Gastroenterology, Qilu Hospital, Shandong University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 14, 2011

Record last verified: 2009-12

Locations

CN(1)