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Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The use of sevoflurane has been identified as one of the most important risk factors. In the investigators' studyļ¼the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ED.
One hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. Anesthesia is induced with propofolļ¼fentanyl and rocuronium. In group P (Placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. In group B (Bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. In group C (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. Maintain BIS values in the range of 40-60. Recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group P (Placebo group) | Placebo Comparator | Patients were assigned to group P (Placebo group) using a computer-generated random number table |
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| group B (Bolus group) | Experimental | Patients were assigned to group B (Bolus group) using a computer-generated random number table |
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| group C (continuous infusion group) | Experimental | Patients were assigned to group C (continuous infusion group) using a computer-generated random number table |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Other | Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of emergence delirium | The pediatric anesthesia emergence delirium 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.pediatric anesthesia emergence delirium scale ā„10 at any time indicates presence of emergence delirium. | Within up to 30 minutes after operation |
| Measure | Description | Time Frame |
|---|---|---|
| End tidal sevoflurane concentration | End tidal sevoflurane concentration at BIS 40-60 | During the preoperative period |
| Pediatric anesthesia emergence delirium | The pediatric anesthesia emergence delirium 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huacheng Liu | Contact | 18957755138 | huachengliu@163.com | |
| Yuhang Cai | Contact | 18815091585 | 838097626@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huacheng Liu | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Yuhang Cai | Second Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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| Bolus Remimazolam | Drug | Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. |
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| Continuous Infusion Remimazolam | Drug | Anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. |
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| Within up to 30 minutes after operation |
| FLACC scale | 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. | Within up to 30 minutes after operation |
| Ramsay Sedation Scale score |
The degree of sedation increased directly with the total score. | Within up to 30 minutes after operation |
| Recovery times | The time from discontinuation of sevoflurane to the first open eye of the children and to achieve aldreteā„9 | Up to 30 minutes after operation |
| Number of children with adverse effects | Number of children with adverse effects Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions | Up to 24 hours including intraoperative, and postoperative periods |
| 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 |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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