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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
96
Intravenous injection 0.1mg/kg esketamine about 5min before the end of the surgery
Intravenous injection 0.2mg/kg esketamine about 5min before the end of the surgery
Intravenous injection 0.1ml/kg normal saline about 5min before the end of the surgery
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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.
Time frame: Within up to 30 minutes after emergence from anesthesia
Tracheal catheter extubation time
The time from the cessation of sevoflurane to the point when the tracheal catheter would be remove.
Time frame: Within up to 30 minutes after operation
emergence from anesthesia time
The time from the cessation of sevoflurane to the point when the child would respond to sound stimuli or open their eyes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after surgery.
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Blood pressure
Blood pressure of children were measured at 0min, 5min, 10min and 20min after injection of study drug or normal saline.
Time frame: 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.
Time frame: Intraoperative and up to postoperative 20 minutes