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Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients without complications, compared with air insufflation. However, differences in patient suffering between CO2 and air insufflation after ERCP depending on sedation protocols have not been reported. We therefore planned prospective, double-blind, randomized, controlled study with CO2 and air insufflation during ERCP depending on sedation protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.](streamdown:incomplete-link) | ||
| 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.](streamdown:incomplete-link) | ||
| 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.](streamdown:incomplete-link) | ||
| 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.](streamdown:incomplete-link) |
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| Measure | Description | Time Frame |
|---|---|---|
| Sedation quality | Abdominal pain, discomfort, and gas accumulation | After patients' alertness (at least 10 minutes later), 3 hrs, and 24 hrs later |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Procedure related complications; pancreatitis, bleeding, cholangitis, or perforation | After completion of procedures (within 2 hrs) and 24 hrs later |
| Procedure outcome |
|
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Inclusion Criteria:
Exclusion Criteria:
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The study had an 80% power to detect a 20% difference in PAIN score any two groups, assuming 2-sided tests at a 5% significance level.Assuming a 10 % dropout rate, 220 patients were needed.
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| Name | Affiliation | Role |
|---|---|---|
| Tae Hoon Lee, PhD | Soonchunhyang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Cheonan Hospital | Cheonan | Chungchungnam-do | 330-721 | South Korea |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| After completion of procedure, within 2hrs |