EGD ProcedureNCT02174588
Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial
A study testing Midazolam + propofol and propofol in people with EGD Procedure, run by Yonsei University at 1 site in South Korea.
Trial summary
Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- EGD Procedure
- What is being tested?
- Midazolam + propofol and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2013to 4 Feb 2015
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 19 years old, male and female
- patients who have plan to get esophagogastroduodenoscopy (EGD)
Who cannot join
- ASA class III or IV
- Allergies to propofol, sulfites or eggs
- patients who had surgery for esophagus, stomach or duodenum
- inpatients
- patients who had sleep apnea, gastroparesis or achalasia
- patients who are taking sedative drugs more than 6 months
Show all 9Show fewer
- pregnancy
- hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%)
- psychiatric or neurologic problems (ex. epilepsy or dementia)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei university College of Medicine
Seoul, Seoul, 120-752
About this study
Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.
- Conditions
- EGD Procedure
- Being tested
- Midazolam + propofol, propofol
- Keywords
- sedation, propofol, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam + propofolDrug
Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.
propofolDrug
propofol are used for sedation drug
| Study group | Role | What they receive |
|---|---|---|
| balanced propofol group | Experimental | Not described Receives: Drug: Midazolam + propofol |
| propofol alone group | Active comparator | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone
Measured: Within the 24 hours after EGD
Secondary outcomes (1)
complications rates
The recovery time after EGD following balanced propofol sedation versus propofol sedation alone. The safety after EGD following balanced propofol sedation versus propofol sedation alone
Measured: Within the 1 hour after EGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study start7 Jan 2013
- Primary completion4 Feb 2015
- Study completion4 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGD ProcedureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174588
- Sponsor's protocol ID
- 4-2012-0801
- Status last verified
- Jan 2017
- First submitted
- 23 Jun 2014
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02174588
- Acronym / sponsor ID
- 4-2012-0801
- Conditions
- EGD Procedure
- Keywords
- sedation, propofol, midazolam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Jan 2013 (actual)
- Primary completion
- 4 Feb 2015 (actual)
- Study completion
- 4 Feb 2015 (actual)
- First posted
- 25 Jun 2014 (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.
Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balanced propofol group | Experimental | Drug: Midazolam + propofol |
| propofol alone group | Active comparator | Drug: propofol |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 19 years old, male and female
- patients who have plan to get esophagogastroduodenoscopy (EGD)
Key exclusion criteria (9 listed)
- ASA class III or IV
- Allergies to propofol, sulfites or eggs
- patients who had surgery for esophagus, stomach or duodenum
- inpatients
- patients who had sleep apnea, gastroparesis or achalasia
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 |
|---|---|---|
| Midazolam + propofolMidazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. | Drug | balanced propofol group |
| propofolpropofol are used for sedation drug | Drug | propofol alone group |
Primary outcome
visual analog scale
Time frame: Within the 24 hours after EGD
The patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone
1 secondary outcome
complications rates
Time frame: Within the 1 hour after EGD
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 25 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam + propofol and propofol in people with EGD Procedure, run by Yonsei University at 1 site in South Korea.
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 9 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 25 Jan 2017. 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 South Korea. 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?
visual analog scale (time frame: Within the 24 hours after EGD). 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 25 Jan 2017.