Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 goal of this clinical trial is to investigate whether a subanesthetic dose of esketamine can reduce incidence of ED.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group S1 (0.1mg/kg esketamine) | Experimental |
| |
| group S2 (0.2mg/kg esketamine) | Experimental |
| |
| group C (0.1ml/kg Normal saline) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1mg/kg esketamine | Drug | Intravenous injection 0.1mg/kg esketamine about 5min before the end of the surgery |
|
| 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 scores ≥10 at any time indicates presence of emergence delirium. | Within up to 30 minutes after emergence from anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Tracheal catheter extubation time | The time from the cessation of sevoflurane to the point when the tracheal catheter would be remove. | Within up to 30 minutes after operation |
| emergence from anesthesia time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310052 | China |
Not provided
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 0.2mg/kg esketamine | Drug | Intravenous injection 0.2mg/kg esketamine about 5min before the end of the surgery |
|
| 0.1ml/kg normal saline | Drug | Intravenous injection 0.1ml/kg normal saline about 5min before the end of the surgery |
|
The time from the cessation of sevoflurane to the point when the child would respond to sound stimuli or open their eyes.
| Within up to 30 minutes after operation |
| The incidence of 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. FLACC scores 4 or greater indicates presence of emergence delirium. | Within up to 30 minutes after operation |
| Recovery time | The time from the cessation of sevoflurane to the point when the child was awakened and responded readily to their name spoken in a normal tone of voice. | Within up to 50 minutes after operation |
| The incidence of adverse effects | Postoperative nausea, vomiting, salivation, bradycardia, hypotension, and respiratory depression within 24 hours after surgery. | 24 hours after surgery. |
| Blood pressure | Blood pressure of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline. | Intraoperative and up to postoperative 20 minutes |
| heart rate | heart rate of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline. | Intraoperative and up to postoperative 20 minutes |