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Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the median effective dose of remimazolam for duodenoscopy insertion during ERCP with alfentanil 10µg/kg.
6. Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent.If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The median effective dose of remimazolam for duodenoscopy insertion with alfentanil 10µg/kg | Experimental | The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size).The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement)' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined as duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. No movement was depicted when the reactions mentioned earlier were absent. If BIS>75 and MOAA/S > 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of success duodenoscopy insertion | success duodenoscopy insertion is defined by no body movement | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianbo Yu, MD | Contact | 86-22-27435873 | yujianbo11@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Nankai Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
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