Comparison of Emergence Delirium: Remimazolam vs Sevoflurane Anesthesia

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

• Remimazolam (Drug), also known as intravenous anesthesia: 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 (Drug), also known as inhalation anesthesia: 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).

Primary outcomes

• 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 outcomes

• 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.
• 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.
• 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

Sex: All, ages: 3 Years to 6 Years

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.

• Results publication: Ma HY, Cai YH, Zhong JW, Chen J, Wang Z, Lin CY, Wang QQ, Liu HC. The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial. Front Pharmacol. 2024 Jun 25;15:1373006. doi: 10.3389/fphar.2024.1373006. eCollection 2024. PMID 38983921

• Huacheng Liu, Ph.D., Principal investigator, Second Affiliated Hospital of Wenzhou Medical University