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OBJECTIVE: To study the safety, efficacy and clinical significance of remimazolam in the diagnosis and treatment of patients with daytime gastrointestinal endoscopy, calculate the optimal dose, and conduct relevant verification. Provide a safer and more effective anesthesia solution for the growing special population.
METHODS：Around 160 patients were selected to receive painless gastroenteroscopy.，they were divided into four groups of D1, D2, R and C. Group D1 and D2(including 60 patients) were used to calculate the ED50 and ED95 of the drug. According to up-and-down method, they were slowly injected 0.3μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg. And the study was terminated when seven crossing points occurred. One hundred patients were randomly divided into two groups of R and C.Before administration of remimazolam, remifentanil injection 0.3 μg/kg were given intravenously in two groups, respectively (injection rate was 30 s).Then group R was given the calculated dose of remimazolam, and group C was given propofol 1.5-2mg/kg.The success rate of sedation, changes in vital signs, adverse reactions, and postoperative recovery were recorded in the two groups.
The study used up-and-down methods to calculate the ED50 and ED95. According to up-and-down method, group D1 and D2 were slowly injected 0.5μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The standard for a positive response in patients undergoing gastroscopy: coughing, swallowing, frowning, and physical movement affecting the operation during the examination. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg.And the study was terminated when seven crossing points occurred. Probit regression analysis method was used to calculate the ED50, ED95 and 95%CI of remimazolam combined with remifentanil in painless gastroenteroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group D1(males) | Experimental | Administration of 0.3μg/kg of remifentanil in advance, then corresponding dose of remimazolam, according to the experimental results of the previous patient. |
|
| group D2(females) | Experimental | Administration of 0.3μg/kg of remifentanil in advance, then corresponding dose of remimazolam, according to the experimental results of the previous patient. |
|
| group R | Experimental | Administration of 0.3μg/kg of remifentanil in advance, then the calculated dose of remimazolam, according to the experimental results of the previous patient. |
|
| group C | Experimental | Administration of 0.3μg/kg of remifentanil in advance, then 1.5-2mg/kg propofol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | 0.3μg/kg of remifentanil was injected slowly in advance, then different doses of Remimazolam was injected to two groups of D1 and D2, according to up-and-down method. |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of sedation | After the administration of remimazolam, observe and record the response | 1-3minutes |
| Blood pressure value | record the blood pressure before and after administration | 1-30minutes |
| Heart rate | record the heart rate before and after administration | 1-30minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | Incidence of adverse reactions such as intraoperative movement, choking, respiratory depression, hiccups, nausea and vomiting, dizziness, laryngospasm | 1-30minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liu M Yu, Director | Yangzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Yangzhou University | Yangzhou | Jiangsu | 225000 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 16, 2025 | |
| Reset | Sep 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2025 | Sep 4, 2025 |
| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Remimazolam | Drug | 0.3μg/kg of remifentanil was injected slowly in advance, then the calculated dose from groups of D1 and D2 of remimazolam was injected to group R. |
|
| Propofol | Drug | 0.3μg/kg of remifentanil was injected slowly in advance, then 1.5-2mg/kg of Propofol was injected to group C |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |