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Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed.
Esophagogastric variceal bleeding (EGVB) is one of the most serious and common complications of liver cirrhosis. Endoscopic hemostasis is the most widely used and important method for the prevention and treatment of EGVB. The treatment of varicose veins hemostasis under gastroscope has the problem of long operation time. Patients are prone to nausea, vomiting and excessive secretions due to nervousness and fear, which affect endoscopic insertion and observation, leading to failure of ligation and massive bleeding, and even death. Therefore, appropriate analgesic and sedative drugs are necessary to ensure endoscopic treatment and improve the prognosis. Remimazolam, an ultra-short-acting benzodiazepine drug, is obtained by introducing metabolizable methyl propionate side chain into midazolam. It may have a good effect on sedation during endoscopic hemostasis in cirrhotic patients with ruptured esophageal and gastric varices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol | Active Comparator | The control group was sedated with propofol |
|
| Remimazolam besylate | Experimental | The experimental group was given remazolam besylate for sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Remifentanil maintenance analgesic dose was 1.2-9 μg/kg/h. If the CPOT score ≥3 at the time of maintenance administration, dose adjustment can be considered. Propofol was used for sedation at a loading dose of 0.5mg/kg and a maintenance dose of 1.5mg/kg/h. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation scores | sedation scores were performed during administration,Richmond Agitation-Sedation Scale(RASS)1~-2 was defined as compliance,Otherwise, sedation was considered inadequate | From the begin to 48 hours after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events | Any adverse events that occurred during the administration of the drug, such as bradycardia, hypotension, respiratory depression, etc | Within 2 hours from the start of administration to the end of administration |
| Vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Wang | Contact | 15927142942 | 410669243@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
All data will be shared with team members
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Remimazolam besylate | Drug | Remifentanil was administered at a maintenance dose of 1.2-9 μg/kg/h for analgesia. If CPOT score ≥3 during maintenance administration, dose adjustment could be considered. For sedation, remazolam besylate was given a load of 0.1-0.2mg/kg and a maintenance dose of 0.1-0.3mg/kg/h. |
|
|
Systolic and Diastolic Blood Pressure
| From the begin to 48 hours after procedure |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |