CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols
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ClinicalTrials.gov Identifier: NCT01761474 |
Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : March 19, 2014
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Condition or disease |
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Satisfaction Complication |
Study Type : | Observational |
Actual Enrollment : | 210 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Carbon Dioxide Insufflations vs. Air Insufflation in Therapeutic ERCP: A Randomized Double-blind Comparative Study Depending on Sedation Methods |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | September 2013 |

Group/Cohort |
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1. Carbon dioxide insufflation with BPS
Both midazolam (0.05 mg/kg body weight; 1 mg if age[70 or ASA class III-IV) and fentanyl (50 lg; 25 lg if age[70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, repeated doses of 10-20 mg propofol were administered to achieve a moderate level of sedation. Maintenance of sedation was also performed with repeated doses of 10-20 mg propofol.
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2. Carbon dioxide insufflation with Propofol
Sedation was induced by intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age[70 or ASA class III-IV), followed by repeated doses of 10-20 mg propofol to induce sedation. Repeated doses of 10-20 mg propofol were then administered to maintain adequate sedation, according to the desired sedation depth and patient risk profile.
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3. Air insufflation with BPS
Both midazolam (0.05 mg/kg body weight; 1 mg if age[70 or ASA class III-IV) and fentanyl (50 lg; 25 lg if age[70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, repeated doses of 10-20 mg propofol were administered to achieve a moderate level of sedation. Maintenance of sedation was also performed with repeated doses of 10-20 mg propofol.
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4. Air insufflation with Propofol
Sedation was induced by intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age[70 or ASA class III-IV), followed by repeated doses of 10-20 mg propofol to induce sedation. Repeated doses of 10-20 mg propofol were then administered to maintain adequate sedation, according to the desired sedation depth and patient risk profile.
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- Sedation quality [ Time Frame: After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later ]Abdominal pain, discomfort, and gas accumulation
- Complications [ Time Frame: After completion of procedures (within 2 hrs) and 24 hrs later ]Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation
- Procedure outcome [ Time Frame: After completion of procedure, within 2hrs ]
- Technical success or fail of procedure
- Procedure quality and satisfaction to patients and endoscopist

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- candidates for therapeutic ERCP
Exclusion Criteria:
- age<18 years
- pregnant women
- total gastrectomy
- uncontrolled coagulopathy
- American Society of Anesthesiologist(ASA) Class V
- neurologic impairment
- known allergy to the drugs used
- history of complications with previous sedation, sedative
- alcohol abuse
- inability to provide informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761474
Korea, Republic of | |
Soon Chun Hyang University Cheonan Hospital | |
Cheonan, Chungchungnam-do, Korea, Republic of, 330-721 |
Principal Investigator: | Tae Hoon Lee, PhD | SoonChunHyang University School of Medicine |
Responsible Party: | Tae Hoon Lee, Professor, Soon Chun Hyang University |
ClinicalTrials.gov Identifier: | NCT01761474 |
Other Study ID Numbers: |
ERCP-Sedation |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | March 19, 2014 |
Last Verified: | March 2014 |
Carbon dioxide insufflation Air insufflatioin ERCP Sedation |