Clinical trial NCT06214117: Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia
Official title: Comparison of Emergence Agitation in Children Following Tonsillectomy and Adenoidectomy Under Remimazolam or Sevoflurane General Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Emergence Delirium
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Sevoflurane anesthesia is also a known cause of postoperative delirium. Therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.

Detailed description: children aged 3-6 years old were randomly and equally allocated into two groups: Group R remimazolam, Group S with sevoflurane, respectively.

Eligibility criteria: Inclusion Criteria:

1. Age 3-6 years;
2. American Society of Anaesthesiologist (ASA) I or II;
3. Booked for Tonsillectomy and Adenoidectomy;
4. BMI for age between the 25th and 85th percentiles according to the 2000 Centers for Disease Control and Prevention (CDC) growth charts.

Exclusion Criteria:

1. Children (ASA III- IV) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction;
2. Allergy or hypersensitive reaction to remimazolam;
3. mental disorder
4. Recently respiratory infection;
5. Other reasons that researchers hold it is not appropriate to participate in this trial: under specialized care or lived in social welfare institutions, or any other factors that could affect their ability to participate in the study.

Primary outcomes:
measure: The incidence of emergence delirium
timeFrame: Within up to 30 minutes after operation
Secondary outcomes:
measure: Pediatric anesthesia emergence delirium
timeFrame: Within up to 30 minutes after operation
measure: The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
timeFrame: Within up to 30 minutes after operation
measure: Extubation time
timeFrame: Within up to 30 minutes after operation
measure: Recovery times
timeFrame: Within up to 30 minutes after operation
measure: PHBQ-AS
timeFrame: 3 days after operation
measure: Number of children with adverse effects
timeFrame: Up to 24 hours including intraoperative, and postoperative periods
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
name: Huacheng Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: