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| Name | Class |
|---|---|
| The Hong Kong Polytechnic University | OTHER |
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The goal of this clinical trial is to compare the efficacy and safety of propofol vs. remimazolam in combine use of esketamine in women with early pregnancy undergoing painless abortion. The main questions it aims to answer are:
Participants will be randomly allocated to two groups: R+E and P+E group.
We will compare R+E with P+E to see if the time to loss of conscious and time to recover from the sedation will be shorter and if there will be less severe adverse events in R+E.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | Intravenous Remimazolam will be co-administrated with esketamine. |
|
| Propofol | Active Comparator | Intravenous Propofol will be co-administrated with esketamine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Total intravenous anaesthesia will be induced with 0.3mg/kg remimazolam and 0.3mg/kg esketamine, slow injection. During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.2 mg/kg remimazolam (IV) will be administrated. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to loss of consciousness | The time from the study drug administration to loss of consciousness | 5 - 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of sedation | Defined as completing the induction of anesthesia without an additional dosage | Intraoperative period, 30 minutes - 1.5 hours |
| Recovery time | Time to fully awake, defined as by a modified Aldrete score which will be recorded every 3 minutes from the end of the procedure with a recovery index (MAS) of 9 or more. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Na Li, MD | Maternal and Child Health Hospital of Hubei Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Hospital of Hubei Province | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| C000629870 | Esketamine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Total intravenous anaesthesia will be induced with 2mg/kg propofol and 0.3mg/kg esketamine, slow injection. During the painless abortion surgery, if the MOAA/S scores > 1 or body movements occur, supplemental 0.25 mg/kg propofol (IV) will be administrated. |
|
| Esketamine | Drug | 0.3mg/kg esketamine will be co-administrated in both arms |
|
| Postoperative 30 minutes |
| Mean arterial pressure (MAP) | MAP level will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), in sedation when vaginal dilator is placed (Time 1), in sedation when curettage begins (Time 2), and postoperative awakening (Time 3). | Intraoperative period, 30 minutes - 1.5 hours |
| Heart rate (HR) | HR will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), in sedation when vaginal dilator is placed (Time 1), in sedation when curettage begins (Time 2), and postoperative awakening (Time 3). | Intraoperative period, 30 minutes - 1.5 hours |
| Adverse events | The adverse events will be monitored and recorded during the operation and post-operation. AE will include: respiratory depression (defined as SpO2< 95%), hypotension (defined as systolic arterial pressure < 80 mmHg, or decreased baseline systolic blood pressure > 20%), hypertension, bradycardia (defined as decrease in HR < 50/min), number of body movements, injection site pain and nausea and vomiting. | Intraoperative and post-operation, 30 minutes - 1.5 hours |
| Post-operative pain | It will be assessed by Visual Analogue Scale (VAS) pain score. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | Post-operation after fully awake, 30 minutes - 1 hour |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |