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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous infusion of propofol | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction scores by endoscopist | 30 minutes after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events for sedation | 1 day after the procedure | |
| Difficulty scores of maintaining the sedation | 30 minutes after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyo-Sang Yoo, MD, PhD | Contact | 82-31-560-2178 | kyoo@hanyang.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kyo-Sang Yoo | Hanyang University Guri Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | 471-701 | South Korea |
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| Intermittent bolus injection of propofol | Procedure | 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. |
|
| Midazolam | Drug |
|
| Propofol | Drug |
|
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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