Biliary Tract DiseasesNCT01900938
Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP
A study testing Continuous infusion of propofol, Intermittent bolus injection of propofol and Midazolam in people with Biliary Tract Diseases and Pancreatic Diseases, run by Hanyang University at 1 site in South Korea.
Trial summary
The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Biliary Tract Diseases, Pancreatic Diseases
- What is being tested?
- Continuous infusion of propofol, Intermittent bolus injection of propofol and Midazolam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to May 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergone ERCP for biliary and pancreatic diseases
Who cannot join
- Comorbid conditions of ASA class 4-5
- Age under 18 years or over 90 years
- Pregnancy
- Past medication history of benzodiazepine or narcotics
- Known allergy to midazolam or propofol
- hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701
Kyo-Sang Yoo, MD, PhD
About this study
Official title: Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study
The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.
Read the detailed description
The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Being tested
- Continuous infusion of propofol, Intermittent bolus injection of propofol, Midazolam, Propofol
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde
- Medical subject headings
- Biliary Tract Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous infusion of propofolProcedure or surgery
Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
Intermittent bolus injection of propofolProcedure or surgery
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
MidazolamDrug
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Intermittent bolus injection of propofol | Active comparator | A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level. Receives: Procedure: Intermittent bolus injection of propofol; Drug: Midazolam; Drug: Propofol |
| Continuous infusion of propofol | Active comparator | Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level. Receives: Procedure: Continuous infusion of propofol; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction scores by endoscopist
Measured: 30 minutes after the procedure
Secondary outcomes (2)
Adverse events for sedation
Measured: 1 day after the procedure
Difficulty scores of maintaining the sedation
Measured: 30 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyo-Sang Yoo, Hanyang University
- Investigators
- Kyo-Sang Yoo, Principal investigator, Hanyang University Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900938
- Sponsor's protocol ID
- 2012-055
- Status last verified
- Jul 2013
- First submitted
- 29 May 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01900938
- Acronym / sponsor ID
- 2012-055
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 17 Jul 2013 (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.
The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.
Detailed description
The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent bolus injection of propofol | Active comparator | Procedure: Intermittent bolus injection of propofol, Drug: Midazolam, Drug: PropofolA loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level. |
| Continuous infusion of propofol | Active comparator | Procedure: Continuous infusion of propofol, Drug: PropofolPropofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergone ERCP for biliary and pancreatic diseases
Key exclusion criteria (6 listed)
- Comorbid conditions of ASA class 4-5
- Age under 18 years or over 90 years
- Pregnancy
- Past medication history of benzodiazepine or narcotics
- Known allergy to midazolam or 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 |
|---|---|---|
| Continuous infusion of propofolPropofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level. | Procedure or surgery | Continuous infusion of propofol |
| Intermittent bolus injection of propofolA loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level. | Procedure or surgery | Intermittent bolus injection of propofol |
| Midazolam | Drug | Intermittent bolus injection of propofol |
| Propofol | Drug | Continuous infusion of propofol, Intermittent bolus injection of propofol |
Primary outcome
Satisfaction scores by endoscopist
Time frame: 30 minutes after the procedure
2 secondary outcomes
Adverse events for sedation
Time frame: 1 day after the procedure
Difficulty scores of maintaining the sedation
Time frame: 30 minutes after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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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.
Kyo-Sang Yoo principal investigator
Hanyang University Guri Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous infusion of propofol, Intermittent bolus injection of propofol and Midazolam in people with Biliary Tract Diseases and Pancreatic Diseases, run by Hanyang 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 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyo-Sang Yoo, MD, PhD (82-31-560-2178, kyoo@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction scores by endoscopist (time frame: 30 minutes after 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 17 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.