As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
110
Anesthesia was induced with Remimazolam 0.4-0.8 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h until the end of surgery.
Anesthesia was induced with 8 % Sevoflorane by sevoflurane volatilization tank until the loss of consciousness (LoC), followed by 2 %-3 % Sevoflorane until the end of surgery.
Anesthesia was induced with fentanyl 3-4 ug/kg by intravenous injection after the LoC.
Anesthesia was induced with cisatracurium besilate 0.1 mg/kg by intravenous injection after the LoC. And the cisatracurium besilate 0.02 mg/kg is allowed to add as appropriate during the operation.
After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.
the Second Affiliated Hospital of Nanchang University, Nanchang University
Nanchang, Jiangxi, China
The incidence of emergence agitation
The PAED 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. PAED scale \>12 at any time indicates presence of emergence agitation.
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The incidence of emergence agitation
The Watcha scale consists of four items and scores \>2 at any time indicates presence of emergence agitation.
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
The incidence of emergence agitation
The 5-point scale consists of five items. The scores ≥4 and lasts for more than 5 minutes indicate presence of emergence agitation.
Time frame: Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes
Systolic pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Diastolic pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Mean pressure
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Heart rate
"30 minutes before induction", "immediately after intubation", "every 5 minutes after intubation until the child leaves the post-anesthesia care unit and returns to the ward".
Time frame: Up to 5 hours including preoperative, intraoperative, and postoperative periods
Recovery times
The period from discontinuation of anesthetic drugs to the recovery of the child's self-consciousness and can respond correctly to external stimuli.
Time frame: Up to 30 minutes after operation
Delayed emergence
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Time frame: Up to 30 minutes after operation
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.
Time frame: During the recovery from anesthesia.
Complication
All the perioperative complications are recorded.
Time frame: During the perioperative period
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