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

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    86
  • sponsor
    Second Affiliated Hospital of Nanchang University
Updated on 11 October 2022

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).

Details
Condition Emergence Agitation, Remimazolam, Sevoflurane, Pediatric Ophthalmic Surgery, Anesthesia, General
Treatment Fentanyl, Sevoflurane, Remifentanil, Remimazolam, Cisatracurium Besylate
Clinical Study IdentifierNCT05527314
SponsorSecond Affiliated Hospital of Nanchang University
Last Modified on11 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ASA Ⅰ-Ⅱ
Aged 3-8 years, weight > 10 kg, sex was not limited;
Children were scheduled for selective ophthalmic surgery under general anesthesia

Exclusion Criteria

Respiratory infection was present within 4 weeks before surgery
Potential or presence of difficult airways, airway obstruction, sleep apnea, and other contraindications to general anesthesia
The blood routine or blood biochemical indexes were obviously abnormal
Allergy or hypersensitive reaction to test drug, including remimazolam, sevoflurane, and remifentanil
Any child who has taken benzodiazepines in the last 3 months
Unable to cooperate to complete the test, and the guardian refused to attend
Other reasons that researchers hold it is not appropriate to participate in this trial
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