Emergence Delirium
Conditions
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.
Interventions
DRUGRemimazolam
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).
DRUGSevoflurane
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).
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactHuacheng Liu, Ph.D.
Backup ContactYuhang Cai, M.D.
Outcome results
None listed