Emergence Delirium, Neurosurgery, Pediatric, Remimazolam, Sevoflurane Anesthesia
Conditions
Keywords
emergence delirium, remimazolam, pediatric, neurosurgery, sevoflurane anesthesia
Brief summary
Emergence delirium is a common complication in pediatrics undergoing neurosurgery. Previous study showed that a single bolus of remimazolam was associated with lower incidence of postoperative agitation. Present study was designed to investigate if remimazolam supplemented to sevoflurane anesthesia could decrease the risk of emergence delirium in pediatrics undergoing neurosurgery.
Interventions
DRUGRemimazolam
After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of remimazolam), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of remimazolam). The infusion is expected to stop 10 minutes before the end of the surgery.
DRUGNormal Saline
After anesthesia induction, a loading investigational drug at a rate of \[3.6\*kg\] ml/h (lasting for 5 minutes, equivalent to 0.3 mg/kg of normal saline), and then adjust the infusion rate to \[1\*kg\] ml/h (equivalent to 1 mg/kg of normal saline). The infusion is expected to stop 10 minutes before the end of the surgery.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Aged 1 to 6 years old * Planned to receive elective neurosurgery under general anesthesia * Expected duration of surgery \> 1 hour
Exclusion criteria
* Allergy to benzodiazepine * Use of other sedatives within 12 hours before surgery such as benzodiazepines, propofol, chloral hydrate, etc., * ASA classification IV or above * Unable to complete emergence delirium assessment, such as language, hearing or vision impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence delirium | The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge | The Cornell Assessment of Pediatric Delirium (CAPD) was used to assess delirium. It consists of a total of 8 items, with each item scored from 0 to 4. Delirium can be diagnosed when the total score is ≥ 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery | The Cornell Assessment of Pediatric Delirium (CAPD) scale was used to assess whether the subjects developed delirium. It consists of a total of 8 items, with each item scored from 0 to 4. Delirium can be diagnosed when the total score is ≥ 10. |
| Pain score | Pain intensity was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery | The FLACC behavioral rating scale was used to evaluate the pain intensity. It mainly includes five indicators: Facial Expression, Legs, Activity, Cry, and Consolability. The score is the sum of the above five indicators, ranging from a minimum of 0 to a maximum of 10. A higher score indicates more obvious discomfort and pain. |
| Sleep quality within 3 days after surgery | Within 3 days after surgery | The Numeric Rating Scale (NRS) was used for sleep quality assessment of children by their parents/caregivers within 3 days after surgery. The scores of NRS ranging from a minimum of 0 to a maximum of 10. A lower score indicates poorer sleep quality. |
| Sleep quality 7 days after surgery and 1 month after surgery | 7 days after surgery and 1 month after surgery | The Tayside Children's Sleep Questionnaire (TCSQ) was adopted to assess the sleep quality 7 days after surgery and 1 month after surgery.The TCSQ consists of 10 questions, with scores ranging from a minimum of 0 to a maximum of 40. A higher score indicates poorer sleep quality. |
| Postoperative adverse behavior change | 1st, 3rd days after surgery | Post-hospitalization behavior questionnaire (PHBQ) was used to evaluate the postoperative adverse behavior change. It consists of 26 items, with scores ranging from a minimum of -52 to a maximum of 52. A higher score indicates poorer sleep quality. |
Countries
China
Contacts
Primary ContactDong-liang Mu
Outcome results
None listed