PediatricPhase 4NCT07046364
Remimazolam and Emergence Delirium in Pediatrics
A Phase 4 study testing Remimazolam and Normal Saline in people with Pediatric and Neurosurgery, run by Peking University First Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Pediatric, Neurosurgery, Sevoflurane Anesthesia
- What is being tested?
- Remimazolam and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 1 to 6 years old
- Planned to receive elective neurosurgery under general anesthesia
- Expected duration of surgery > 1 hour
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Liang Mu, Dr., +86 010 83575138, mudongliang@bjmu.edu.cn
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Dong-Liang Mu, +8601083575138, mudongliang@bjmu.edu.cn
About this study
Official title: The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia
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.
- Conditions
- Pediatric, Neurosurgery, Sevoflurane Anesthesia, Remimazolam, Emergence Delirium
- Being tested
- Remimazolam, Normal Saline
- Keywords
- emergence delirium, remimazolam, pediatric, neurosurgery, sevoflurane anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge
Secondary outcomes (5)
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.
Measured: Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery
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.
Measured: 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
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.
Measured: Within 3 days after surgery
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.
Measured: 7 days after surgery and 1 month after surgery
Postoperative adverse behavior change
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.
Measured: 1st, 3rd days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mu Dong Liang, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046364
- Sponsor's protocol ID
- 2024-407-002
- Status last verified
- Dec 2024
- First submitted
- 15 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT07046364
- Acronym / sponsor ID
- 2024-407-002
- Conditions
- Pediatric, Neurosurgery, Sevoflurane Anesthesia, Remimazolam, Emergence Delirium
- Keywords
- emergence delirium, remimazolam, pediatric, neurosurgery, sevoflurane anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: RemimazolamA 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. |
| Normal saline group | Placebo comparator | Drug: Normal SalineAn identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 1 to 6 years old
- Planned to receive elective neurosurgery under general anesthesia
- Expected duration of surgery > 1 hour
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamAfter 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 | Remimazolam group |
| Normal SalineAfter 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. | Drug | Normal saline group |
Primary outcome
Emergence delirium
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and Normal Saline in people with Pediatric and Neurosurgery, run by Peking University First Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong-liang Mu (+86 010 83575138, mudongliang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence delirium (time frame: The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.