Inguinal Hernia
Conditions
Brief summary
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.
Interventions
DRUG0.1mg/kg esketamine
Intravenous injection 0.1mg/kg esketamine about 5min before the end of the surgery
DRUG0.2mg/kg esketamine
Intravenous injection 0.2mg/kg esketamine about 5min before the end of the surgery
DRUG0.1ml/kg normal saline
Intravenous injection 0.1ml/kg normal saline about 5min before the end of the surgery
Sponsors
Qiu jinpeng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
1. laparoscopic inguinal hernia repair under general anesthesia 2. aged 24\ 71 months 3. American Society of Anesthesiologists Physical Status I or II 4. body mass index for age between the 5th and 85th percentiles
Exclusion criteria
1. allergy to esketamine 2. abnormal liver or kidney function 3. glaucoma or neurological disorders 4. cardiovascular or endocrine dysfunction 5. asthma or respiratory infection in the last 2 weeks 6. developmental delay
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of emergence delirium | Within up to 30 minutes after emergence from anesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| emergence from anesthesia time | Within up to 30 minutes after operation | The time from the cessation of sevoflurane to the point when the child would respond to sound stimuli or open their eyes. |
| The incidence of postoperative pain | Within up to 30 minutes after operation | 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. |
| Recovery time | Within up to 50 minutes after operation | 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. |
| Tracheal catheter extubation time | Within up to 30 minutes after operation | The time from the cessation of sevoflurane to the point when the tracheal catheter would be remove. |
| Blood pressure | Intraoperative and up to postoperative 20 minutes | Blood pressure of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline. |
| heart rate | Intraoperative and up to postoperative 20 minutes | heart rate of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline. |
| The incidence of adverse effects | 24 hours after surgery. | Postoperative nausea, vomiting, salivation, bradycardia, hypotension, and respiratory depression within 24 hours after surgery. |
Countries
China
Outcome results
None listed