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As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental |
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| Sevoflorane | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | Anesthesia was induced with Remimazolam 0.4-0.8 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h until the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of emergence agitation | The PAED scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. PAED scale >12 at any time indicates presence of emergence agitation. | Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes |
| The incidence of emergence agitation | The Watcha scale consists of four items and scores >2 at any time indicates presence of emergence agitation. | Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes |
| The incidence of emergence agitation | The 5-point scale consists of five items. The scores ≥4 and lasts for more than 5 minutes indicate presence of emergence agitation. | Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic pressure | "30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward". | Up to 5 hours including preoperative, intraoperative, and postoperative periods |
| Diastolic pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Nanchang University, Nanchang University | Nanchang | Jiangxi | China |
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This is a RCTs.
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Care provider and investigator (anesthesiologist) cannot be blinded for different appearance of sevoflurane and remimazolam.
| Sevoflurane | Drug | Anesthesia was induced with 8 % Sevoflorane by sevoflurane volatilization tank until the loss of consciousness (LoC), followed by 2 %-3 % Sevoflorane until the end of surgery. |
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| Fentanyl | Drug | Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC. |
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| Cisatracurium Besylate | Drug | Anesthesia was induced with cisatracurium besilate 0.1 mg/kg by intravenous injection after the LoC. And the cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate during the operation. |
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| Remifentanil | Drug | After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery. |
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"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward". |
| Up to 5 hours including preoperative, intraoperative, and postoperative periods |
| Mean pressure | "30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward". | Up to 5 hours including preoperative, intraoperative, and postoperative periods |
| Heart rate | "30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward". | Up to 5 hours including preoperative, intraoperative, and postoperative periods |
| Recovery times | The period from discontinuation of anesthetic drugs to the recovery of the child's self-consciousness and can respond correctly to external stimuli. | Up to 30 minutes after operation |
| Delayed emergence | Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery. | Up to 30 minutes after operation |
| Postoperative Pain | The FLACC scale consists of fIve items. Each item is scored 0-2 yielding a total between 0 and 10. The degree of pain increased directly with the total score. | During the recovery from anesthesia. |
| Complication | All the perioperative complications are recorded. | During the perioperative period |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D000077149 | Sevoflurane |
| D005283 | Fentanyl |
| C101584 | cisatracurium |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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