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Emergence delirium is a common complication in pediatrics undergoing neurosurgery. Previous study showed that a single bolus of remimazolam was associated with lower incidence of postoperative agitation. Present study was designed to investigate if remimazolam supplemented to sevoflurane anesthesia could decrease the risk of emergence delirium in pediatrics undergoing neurosurgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | A loading dose of remimazolam 0.3 mg/Kg was given at anesthesia induction and followed with 1 mg/Kg/h until 10 minutes before the end of surgery. Sevoflurane was used to maintain BIS between 40-60. |
|
| Normal saline group | Placebo Comparator | An identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | After anesthesia induction, a loading investigational drug at a rate of [3.6*kg] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of remimazolam), and then adjust the infusion rate to [1*kg] ml/h (equivalent to 1 mg/kg of remimazolam). The infusion is expected to stop 10 minutes before the end of the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergence delirium | The Cornell Assessment of Pediatric Delirium (CAPD) was used to assess delirium. It consists of a total of 8 items, with each item scored from 0 to 4. Delirium can be diagnosed when the total score is ≥ 10. | The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium | The Cornell Assessment of Pediatric Delirium (CAPD) scale was used to assess whether the subjects developed delirium. It consists of a total of 8 items, with each item scored from 0 to 4. Delirium can be diagnosed when the total score is ≥ 10. | Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-liang Mu | Contact | +86 010 83575138 | mudongliang@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Normal Saline | Drug | After anesthesia induction, a loading investigational drug at a rate of [3.6*kg] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of normal saline), and then adjust the infusion rate to [1*kg] ml/h (equivalent to 1 mg/kg of normal saline). The infusion is expected to stop 10 minutes before the end of the surgery. |
|
| Pain score | The FLACC behavioral rating scale was used to evaluate the pain intensity. It mainly includes five indicators: Facial Expression, Legs, Activity, Cry, and Consolability. The score is the sum of the above five indicators, ranging from a minimum of 0 to a maximum of 10. A higher score indicates more obvious discomfort and pain. | Pain intensity was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery |
| Sleep quality within 3 days after surgery | The Numeric Rating Scale (NRS) was used for sleep quality assessment of children by their parents/caregivers within 3 days after surgery. The scores of NRS ranging from a minimum of 0 to a maximum of 10. A lower score indicates poorer sleep quality. | Within 3 days after surgery |
| Sleep quality 7 days after surgery and 1 month after surgery | The Tayside Children's Sleep Questionnaire (TCSQ) was adopted to assess the sleep quality 7 days after surgery and 1 month after surgery.The TCSQ consists of 10 questions, with scores ranging from a minimum of 0 to a maximum of 40. A higher score indicates poorer sleep quality. | 7 days after surgery and 1 month after surgery |
| Postoperative adverse behavior change | Post-hospitalization behavior questionnaire (PHBQ) was used to evaluate the postoperative adverse behavior change. It consists of 26 items, with scores ranging from a minimum of -52 to a maximum of 52. A higher score indicates poorer sleep quality. | 1st, 3rd days after surgery |
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
|
| 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 |