Chronic AlcoholismNCT01617707
Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: Study Comparing Midazolam and Propofol With Midazolam
A study testing Midazolam plus propofol and Midazolam in people with Chronic Alcoholism, run by Yonsei University at 1 site in South Korea.
Trial summary
Sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Alcoholism
- What is being tested?
- Midazolam plus propofol and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2012to 30 Jan 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 20
- ECOG ≥ 2
- patient who consents to enroll the trial
Who cannot join
- age < 20
- pregnant or lactating women
- American Society of Anesthesiology (ASA) physical status class V
- chronic pulmonary disease
- history of allergic to propofol
- history of complication of sedation endoscope
- liver failure or hepatic encephalopathy
- who didn't consented to enroll the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: a Prospective, Randomized Study Comparing Midazolam and Propofol With Midazolam
Sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However, midazolam has been used regardless of whether or not alcohol although using midazolam in chronic alcoholics is related to paradoxical reaction, characterized by increased talkativeness, emotional release, excitement, and excessive movement. In recent years, propofol has been used safety and effectively in sedative GI endoscopy because of its potent hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam) with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI endoscopic procedures.
- Conditions
- Chronic Alcoholism
- Being tested
- Midazolam plus propofol, Midazolam
- Keywords
- sedation, endoscopy, midazolam, propofol, chronic alcoholics
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam plus propofolDrug
In both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation.
MidazolamDrug
In both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation.
| Study group | Role | What they receive |
|---|---|---|
| conventional sedation group | Active comparator | midazolam Receives: Drug: Midazolam |
| BPS group | Experimental | midazolam plus propofol Receives: Drug: Midazolam plus propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of endoscopists, nurses and patients
endoscopists and nurses - about 5 minutes after the end of the procedure / patients - upon meeting discharge criteria (modified Aldrete score), an expected average of 20min
Measured: about 5 minutes after the end of the procedure
Secondary outcomes (2)
completion rate of endoscopy
Measured: about 5 minutes after the end of procedure
number of participants with complications
hypoxemia (SpO2<90%), hypotension (SBP<90mmHg), bradycardia (HR<50/min)
Measured: participants will be followed during the procedure and recovery time, an expected average of 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study start9 May 2012
- Primary completion30 Jan 2015
- Study completion30 Jan 2015
Why it stopped: because of difficulties for participants enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic AlcoholismStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 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
- NCT01617707
- Sponsor's protocol ID
- 4-2012-0181
- Status last verified
- Mar 2014
- First submitted
- 1 Jun 2012
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Effective Sedation in Chronic Alcoholic Patients Underwent Diagnostic Endoscopic Procedures: a Prospective, Randomized Study Comparing Midazolam and Propofol With Midazolam
- ClinicalTrials.gov ID
- NCT01617707
- Acronym / sponsor ID
- 4-2012-0181
- Conditions
- Chronic Alcoholism
- Keywords
- sedation, endoscopy, midazolam, propofol, chronic alcoholics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because of difficulties for participants enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 9 May 2012 (actual)
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 12 Jun 2012 (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.
Sedative endoscopic examination using sedative premedication has been undertaken to induce conscious sedation for comfortable and painless endoscopy. Midazolam has been most widely used as a sedative premedication because it has lots of advantages, such as a short half-life, a faster onset of sedation and an excellent sedative hypnotic effect. However, midazolam has been used regardless of whether or not alcohol although using midazolam in chronic alcoholics is related to paradoxical reaction, characterized by increased talkativeness, emotional release, excitement, and excessive movement. In recent years, propofol has been used safety and effectively in sedative GI endoscopy because of its potent hypnotic effect and its ultrashort pharmacokinetic profile. Therefore, The present study was conducted to compare the safety and efficacy of BPS (propofol in combination with midazolam) with conventional sedation (midazolam) in chronic alcoholic patients undergoing diagnostic GI endoscopic procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional sedation group | Active comparator | Drug: Midazolammidazolam |
| BPS group | Experimental | Drug: Midazolam plus propofolmidazolam plus propofol |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 20
- ECOG ≥ 2
- patient who consents to enroll the trial
Key exclusion criteria (8 listed)
- age < 20
- pregnant or lactating women
- American Society of Anesthesiology (ASA) physical status class V
- chronic pulmonary disease
- history of allergic to propofol
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 plus propofolIn both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation. | Drug | BPS group |
| MidazolamIn both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation. | Drug | conventional sedation group |
Primary outcome
Satisfaction of endoscopists, nurses and patients
Time frame: about 5 minutes after the end of the procedure
endoscopists and nurses - about 5 minutes after the end of the procedure / patients - upon meeting discharge criteria (modified Aldrete score), an expected average of 20min
2 secondary outcomes
completion rate of endoscopy
Time frame: about 5 minutes after the end of procedure
number of participants with complications
Time frame: participants will be followed during the procedure and recovery time, an expected average of 20 min
Results and safety
The study was stopped early (reason given: because of difficulties for participants enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 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 plus propofol and Midazolam in people with Chronic Alcoholism, 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Nov 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 was stopped early (reason given: because of difficulties for participants enrollment). Results are not available in the source record.
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?
Satisfaction of endoscopists, nurses and patients (time frame: about 5 minutes after the end of the procedure). 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 28 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.