Remimazolam and Emergence Delirium in Pediatrics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam, Normal Saline.
- Who it may be relevant to
- Registry conditions: Pediatric, Neurosurgery, Sevoflurane Anesthesia, Remimazolam. Basic parameters: 1 year — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia
Overview
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
- Drug Remimazolam
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. - Drug Normal 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.
Primary outcome measures
- Emergence delirium [Time frame: The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge]
Secondary outcome measures (5)
- Postoperative delirium [Time frame: Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery]
- Pain score [Time frame: Pain intensity was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery]
- Sleep quality within 3 days after surgery [Time frame: Within 3 days after surgery]
- Sleep quality 7 days after surgery and 1 month after surgery [Time frame: 7 days after surgery and 1 month after surgery]
- Postoperative adverse behavior change [Time frame: 1st, 3rd days after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Peking University First Hospital — Beijing
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07046364 · 2024-407-002