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We conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk endoscopic retrograde cholangiopancreatography (ERCP) could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications.
Remimazolam is a novel ultra-short-acting benzodiazepine-like anesthetic used for gastrointestinal endoscopic procedures, characterized by predictable sedation duration and rapid recovery. Propofol, commonly used in clinical practice as an intravenous anesthetic, also exhibits rapid onset, short duration, and quick recovery characteristics. To date, there is relatively limited literature comparing the likelihood of intraoperative hypotension during general anesthesia with these two agents in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Additionally, a comparison is needed regarding the frequency of additional sedative doses required during anesthesia induction and the occurrence of major postoperative complications, including pancreatitis.
Therefore, the investigators we conducted a randomized trial to investigate whether the administration of Remimazolam in patients undergoing high-risk ERCP could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications. The investigators aimed to enroll 60 patients with a 1:1 ratio of ASA III to IV undergoing ERCP. The investigators anticipate that Remimazolam can reduce intraoperative hypotension, acute postoperative pancreatitis, and the occurrence of major organ complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving Remimazolam | Experimental |
| |
| patients without Remimazolam | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | novel ultra-short-acting benzodiazepine-like anesthetic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the duration and severity of hypotension checklist | during the ERCP examination | 1 day (during the ERCP examination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chih-Jun Lai, MD | Contact | _886-972652086 | littlecherrytw@gmail.com |
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due to patients' privacy
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| ID | Term |
|---|---|
| C522201 | remimazolam |
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One patients receiving Remimazolam, the other patients receiving placebo
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| placebo | Drug | normal saline (compared to Remimazolam) |
|