Emergence Agitation, Remimazolam, Sevoflurane, Pediatric Ophthalmic Surgery, Anesthesia, General
Conditions
Keywords
Anesthesia, General, Pediatric ophthalmic surgery, Emergence Agitation, Remimazolam, Sevoflurane
Brief summary
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).
Interventions
DRUGRemimazolam
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.
DRUGSevoflurane
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.
DRUGFentanyl
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.
DRUGRemifentanil
After the LoC, remifentanil 0.1\ 0.3 ug/kg/min inject intravenously until the end of surgery.
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Care provider and investigator (anesthesiologist) cannot be blinded for different appearance of sevoflurane and remimazolam.
Intervention model description
This is a RCTs.
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
1. ASA Ⅰ-Ⅱ 2. Aged 3-8 years, weight \> 10 kg, sex was not limited； 3. Children were scheduled for selective ophthalmic surgery under general anesthesia,
Exclusion criteria
1. Respiratory infection was present within 4 weeks before surgery. 2. Potential or presence of difficult airways, airway obstruction, sleep apnea, and other contraindications to general anesthesia. 3. The blood routine or blood biochemical indexes were obviously abnormal. 4. Allergy or hypersensitive reaction to test drug, including remimazolam, sevoflurane, and remifentanil. 5. Any child who has taken benzodiazepines in the last 3 months. 6. Unable to cooperate to complete the test, and the guardian refused to attend. 7. Other reasons that researchers hold it is not appropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of emergence agitation | Duration from the time patients arrived the post-anesthesia care unit to the time of leaving to the ward, average 30 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic pressure | Up to 5 hours including preoperative, intraoperative, and postoperative periods | 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. |
| Mean pressure | Up to 5 hours including preoperative, intraoperative, and postoperative periods | 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. |
| Heart rate | Up to 5 hours including preoperative, intraoperative, and postoperative periods | 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. |
| Systolic pressure | Up to 5 hours including preoperative, intraoperative, and postoperative periods | 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. |
| Delayed emergence | Up to 30 minutes after operation | Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery. |
| Postoperative Pain | During the recovery from anesthesia. | 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. |
| Complication | During the perioperative period | All the perioperative complications are recorded. |
| Recovery times | Up to 30 minutes after operation | The period from discontinuation of anesthetic drugs to the recovery of the child's self-consciousness and can respond correctly to external stimuli. |
Countries
China
Outcome results
None listed