GastritisNCT01053871
Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy
A study testing propofol and midazolam with fentanyl in people with Gastritis and Functional Dyspepsia, run by Shandong University at 1 site in China.
Trial summary
This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastritis, Functional Dyspepsia
- What is being tested?
- propofol and midazolam with fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients attending endomicroscopy
- able to give written informed consent
Who cannot join
- GI tract malignancy
- coagulopathy
- acute upper digestive tract bleeding
- pregnancy or breast feeding
- allergy to fluorescein sodium
- impaired renal function
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong
About this study
This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.
- Conditions
- Gastritis, Functional Dyspepsia
- Being tested
- propofol, midazolam with fentanyl
- Keywords
- normal
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
conscious sedation using propofol
midazolam with fentanylDrug
conscious sedation using midazolam with fentanyl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | sedation using propofol Receives: Drug: propofol |
| 2 | Experimental | sedation using midazolam with fentanyl Receives: Drug: midazolam with fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
endomicroscopic image quality
Measured: 3 months
Secondary outcomes (1)
sedation efficacy outcomes,patient assessment,physician assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Investigators
- Yanqing Li, PhD. MD., Study director, Department of Gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053871
- Sponsor's protocol ID
- 2009SDU-QILU-G08
- Status last verified
- Dec 2009
- First submitted
- 21 Jan 2010
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy
- ClinicalTrials.gov ID
- NCT01053871
- Acronym / sponsor ID
- 2009SDU-QILU-G08
- Conditions
- Gastritis, Functional Dyspepsia
- Keywords
- normal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: propofolsedation using propofol |
| 2 | Experimental | Drug: midazolam with fentanylsedation using midazolam with fentanyl |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- outpatients attending endomicroscopy
- able to give written informed consent
Key exclusion criteria (6 listed)
- GI tract malignancy
- coagulopathy
- acute upper digestive tract bleeding
- pregnancy or breast feeding
- allergy to fluorescein sodium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolconscious sedation using propofol | Drug | 1 |
| midazolam with fentanylconscious sedation using midazolam with fentanyl | Drug | 2 |
Primary outcome
endomicroscopic image quality
Time frame: 3 months
1 secondary outcome
sedation efficacy outcomes,patient assessment,physician assessment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, PhD. MD. study director
Department of Gastroenterology, Qilu Hospital, Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and midazolam with fentanyl in people with Gastritis and Functional Dyspepsia, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endomicroscopic image quality (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.