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| Name | Class |
|---|---|
| Shanghai East Hospital | OTHER |
| Affiliated Hospital of Jiaxing University | OTHER |
| The Second Affiliated Hospital of Jiaxing University | OTHER |
| The First Affiliated Hospital of Nanchang University |
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Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Propofol（1.5mg/kg） |
|
| Test group 1（Remimazolam tosylate 0.15mg/kg） | Experimental | Remimazolam tosylate 0.15mg/kg |
|
| Test group 2（Remimazolam tosylate 0.2mg/kg） | Experimental | Remimazolam tosylate 0.2mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam tosylate | Drug | Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment | 1) Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation induction time | induction time | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Sedation recovery time | recovery time |
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Inclusion Criteria:
- 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2\
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, Dr. | Contact | +862168383702 | diansansu@yahoo.com | |
| Huichen zhu, M.S. | Contact | +862168383702 | diansansu@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai, China | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36510290 | Derived | Zhu H, Su Z, Huai X, Chen C, Zhang X, Zhou J, Su D. Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial. Trials. 2022 Dec 12;23(1):995. doi: 10.1186/s13063-022-06935-0. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
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| ID | Term |
|---|---|
| C573194 | 4-methylbenzenesulfonic acid |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| OTHER |
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|
| Propofol | Drug | Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. |
|
| Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Incidence of drug injection pain | drug injection pain | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Doctor satisfaction and patient satisfaction | There is a scale from 1 to 10. Endoscopists and patients will score their satisfaction with the scale ,with 1-3 (dissatisfied),4-6 (satisfied) and 7-10 (very satisfied) after gastroscopy. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points; | Sedation/Anaesthesia Discharge Rating Scale | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| The incidence of hypoxia during sedation | (75% ≤ SpO2 < 90% for <60 s)；(SpO2 < 75% for any duration or 75% < SpO2 < 90% for >/=60 s) | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Other adverse events assessed by the World SIVA adverse sedation event reporting tool | other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events. | Patients will be followed for the duration of hospital stay, an expected average of 2 hours |
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai, China | 200127 | China |
|
| Affiliated Hospital of Jiaxing University | Recruiting | Jiaxing | China |
|
| The Second Affifiliated Hospital of Jiaxing University | Recruiting | Jiaxing | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |