Remimazolam and Emergence Delirium in Pediatrics
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-6
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 1 to 6 years old
Planned to receive elective neurosurgery under general anesthesia
Expected duration of surgery > 1 hour
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugAfter 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.
Normal Saline
DrugAfter 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.
Treatment groups
248 Participants
are divided into 2 treatment groupsGroup A: Remimazolam groupExperimental treatment 1 intervention
Group B: Normal saline groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Emergence delirium
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.
Time frame
The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before dischargeSecondary outcomes
1
Postoperative delirium
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.
Time frame
Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery2
Pain score
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.
Time frame
Pain intensity was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery3
Sleep quality 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.
Time frame
Within 3 days after surgery4
Sleep quality 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.
Time frame
7 days after surgery and 1 month after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov