NCT07046364

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_4

Timeline
6mo left

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Jan 2025Jan 2027

Study Start

First participant enrolled

January 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 1, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

June 15, 2025

Last Update Submit

June 28, 2025

Conditions

PediatricNeurosurgerySevoflurane AnesthesiaRemimazolamEmergence Delirium

Keywords

emergence deliriumremimazolampediatricneurosurgerysevoflurane anesthesia

Outcome Measures

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.

    The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge

Secondary Outcomes (5)

  • Postoperative delirium

    Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery

  • 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

  • Sleep quality within 3 days after surgery

    Within 3 days after surgery

  • Sleep quality 7 days after surgery and 1 month after surgery

    7 days after surgery and 1 month after surgery

  • Postoperative adverse behavior change

    1st, 3rd days after surgery

Study Arms (2)

Remimazolam group

EXPERIMENTAL

A loading dose of remimazolam 0.3 mg/Kg was given at anesthesia induction and followed with 1 mg/Kg/h until 10 minutes before the end of surgery. Sevoflurane was used to maintain BIS between 40-60.

Drug: Remimazolam

Normal saline group

PLACEBO COMPARATOR

An identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60

Drug: Normal Saline

Interventions

RemimazolamDRUG

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.

Remimazolam group
Normal SalineDRUG

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.

Normal saline group

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 1 to 6 years old
  • Planned to receive elective neurosurgery under general anesthesia
  • Expected duration of surgery \> 1 hour

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolamSaline Solution

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Dong-liang Mu

CONTACT

+86 010 83575138mudongliang@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 1, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)