Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia

Phase 4

Not yet recruiting

• Conditions: Emergence Delirium
• Interventions: Drug: Remimazolam; Drug: Sevoflurane

• Registration Number: NCT06214117
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Study Start: 2024-02
• Primary Completion: 2025-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group R	Remimazolam	Induction of anesthesia:Anesthesia will induced with remimazolam at 0.3-0.5 mg/kg; Maintenance of anaesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h).
Group S	Sevoflurane	Induction of anesthesia:Anesthesia will induced with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min; Maintenance of anaesthesia:Anesthesia depth was maintained at 1-1.5 MAC by sevoflurane.

Primary Outcome Measures

Name	Time	Method
The incidence of emergence delirium	Within up to 30 minutes after operation	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.

Secondary Outcome Measures

Name	Time	Method
Extubation time	Within up to 30 minutes after operation	The time from discontinuation of anesthesia drug to extubation.
Recovery times	Within up to 30 minutes after operation	The time from discontinuation of anesthesia drug to the first open eye of the children and to achieve aldrete≥9
PHBQ-AS	3 days after operation	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.
Number of children with adverse effects	Up to 24 hours including intraoperative, and postoperative periods	Bradycardia and/or hypotension need for hemodynamic support Desaturation is defined as Oxygen desaturation \<90% Any adverse effects requiring interventions
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)	Within up to 30 minutes after operation	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.
Pediatric anesthesia emergence delirium	Within up to 30 minutes after operation	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.

Trial Locations

Locations (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China