Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia

Emergence Delirium Clinical Trial

— CEDCRSA  

Official title:

Comparison of Emergence Agitation in Children Following Tonsillectomy and Adenoidectomy Under Remimazolam or Sevoflurane General Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214117
• Other study ID #: SAHoWMU-CR2024-03-103
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 2024
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Huacheng Liu, Ph.D.
• Phone: 13957770577
• Email: huachengliu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Drug:
• Remimazolam
Anesthesia induction:intravenous Fentanyl 2-3 µg/kg, remimazolam 0.3-0.5 mg/kg and Rocuronium 0.6mg/kg; Maintenance of anesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h), and remifentanil will administer at an initial infusion rate of 0.25 µg/kg/min (0.1-0.5 µg/kg/min).
• Sevoflurane
Anesthesia induction: Anesthesia will induce with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min, and then intravenous fentanyl (2-3 µg/kg) and rocuronium (0.6 mg/kg); Maintenance of anaesthesia: Anesthesia depth will maintain at 1-1.5 minimum alveolar concentration (MAC), and remifentanil was infuse at an initial rate of 0.25 µg/kg/min (0.1-0.5 µg/kg/min).

Locations

Country	Name	City	State
China	The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of emergence delirium	The pediatric anesthesia emergence delirium 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.; Pediatric anesthesia emergence delirium scale =10 at any time indicates presence of emergence delirium.	Within up to 30 minutes after operation
Secondary	Pediatric anesthesia emergence delirium	The pediatric anesthesia emergence delirium 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.	Within up to 30 minutes after operation
Secondary	The Face, Legs, Activity, Cry, Consolability Scale (FLACC)	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.	Within up to 30 minutes after operation
Secondary	Extubation time	The time from discontinuation of anesthesia drug to extubation.	Within up to 30 minutes after operation
Secondary	Recovery times	The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete=9	Within up to 30 minutes after operation
Secondary	PHBQ-AS	Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) is a parental report measure used to assess negative behavior change after hospitalization, consisting of 11 items on 1-5 score. The PHBQ-AS score will be calculated for each respondent as the mean score of all individual items answered on the questionnaire.; A score above 3 will indicate the presence of negative behavioral change, a score equal to 3 will indicate no behavioral change, and a score below 3 will indicate an improvement in behavior.	3 days after operation
Secondary	Number of children with adverse effects	Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation <90% Any adverse effects requiring interventions	Up to 24 hours including intraoperative, and postoperative periods