Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery

• Status: Not yet recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Nanchang University
• Treatments: Cisatracurium; Fentanyl; Remifentanil; Sevoflurane

Criteria

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.