RemimazolamNCT07050212
Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
A study testing remimazolam group, dexmedetomidine group and esketamine group in people with Remimazolam and Dexmedetomidine, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial summary
By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Remimazolam, Dexmedetomidine, Esketamine
- What is being tested?
- remimazolam group, dexmedetomidine group and esketamine group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Mar 2026
- Phase
- Interventional
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 2 to 5 years old
- the American Society of Anesthesiologists (ASA) physical status of Class I
- scheduled for adenotonsillectomy under general anesthesia, will be included.
Who cannot join
- Abnormal lung function and respiratory system function
- airway obstruction or deformity, history of mental illness
- electrocardiogram indicating bradycardia
- history of cardiac disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000
About this study
Official title: A Comparative Study of the Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.
Read the detailed description
Participants will be randomly allocated to three groups: remimazolam group(Group A), dexmedetomidine group(Group B), esketamine group(Group C). Before entering the operating room, an intravenous access is established. Under the accompaniment of a parent, one of the three drugs is administered intravenously.
- Conditions
- Remimazolam, Dexmedetomidine, Esketamine
- Being tested
- remimazolam group, dexmedetomidine group, esketamine group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam groupDrug
Also called remimazolam
remimazolam is administered intravenously at a dose of 0.3 mg/kg
dexmedetomidine groupDrug
Also called dexmedetomidine
dexmedetomidine is administered intravenously at a dose of 1 μg/kg
esketamine groupDrug
Also called esketamine
esketamine is administered intravenously at a dose of 0.5 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg | Experimental | Remimazolam is administered intravenously at a dose of 0.3 mg/kg Receives: Drug: remimazolam group |
| dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kg | Active comparator | dexmedetomidine is administered intravenously at a dose of 1 μg/kg Receives: Drug: dexmedetomidine group |
| esketamine group: esketamine is administered intravenously at a dose of 0.5 mg/kg | Active comparator | esketamine is administered intravenously at a dose of 0.5 mg/kg Receives: Drug: esketamine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation success rate
1 points represents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls. If the Ramasay score greater than 2 points, it is considered a successful sedation.
Measured: 0, 3, 5, 10 minutes after the drug injection
Onset time of sedation
The time from the end of drug injection until the Ramsay score is greater than 2 points. If the Ramasay score greater than 2 points, it is considered a successful sedation. 1 points of ramasay scorere presents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls.
Measured: 0, 3, 5, 10 minutes after the drug injection
Parent-Child Separation Anxiety Score (PASA Score)
if the PASA score is greater than 2, it is considered a positive reaction to separation anxiety. 1 point represents that the child is easily separated from their parents；A score of 2 indicates that the child has crying sounds, easily comforted, and does not rely on their parents；A score of 3 indicates that the child is crying and cannot be comforted, but does not rely on their parents；4 points represent the child crying and relying on their parents
Measured: 0, 3, 5, 10 minute after the drug injection
Secondary outcomes (7)
Mask Acceptance Score (MAS)
The MAS scale is used to evaluate the acceptance of respiratory masks in pediatric patients. Less than 2 points indicate satisfactory acceptance. 1 point represents that the child is fearless and easily accepts face masks; 2 points represent that the child is mildly fear of the face mask and easily be comfort; 3 points represent that the child is moderatly fear of the face mask and cannot be comforted; 4 points represent that the child is very afraid of the face mask and crying
Measured: 0, 3, 5, 10 minutes after the drug injection
incidence of adverse reactions
Measured: during intravenous bolus administration of sedative drugs and anesthesia induction
restlessness rating scale for awakening period(PAED)
When the PAED score is greater than 2 points, the child is identified as agitated during the recovery period; if the PAED score is greater than 10 points, the child is identified as delirium in the awakening period.
Measured: 0, 5, 10, 20 minutes after the patient awake
Heart rate
Measured: 0, 3, 5, and 10 minutes after the drug injection
blood pressure
systolic pressure and diastolic pressure
Measured: 0,3,5,10 minute after drug injectuion
respiratory rate
Measured: 0,3,5,10 minute after drug injectuion
pulse oximetry saturation
Measured: 0,3,5,10 minute after drug injectuion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Apr 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Na Li NaLi, MD, Principal investigator, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050212
- Sponsor's protocol ID
- MCHH_013
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I plan to share IPD after the end of this study, including the study protocol, informed consent form and clinical study report.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Application of Remimazolam, Dexmedetomidine, and Esketamine in Pediatric Preoperative Sedation
- ClinicalTrials.gov ID
- NCT07050212
- Acronym / sponsor ID
- MCHH_013
- Conditions
- Remimazolam, Dexmedetomidine, Esketamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 3 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.
By comparing the application effects of three drugs in pediatric preoperative sedation, this study explores the optimal medication regimen, aiming to provide safer, more effective, and more personalized medication options for pediatric preoperative sedation. Additionally, this research will also focus on the impact of these three drugs on postoperative agitation in children, offering valuable references for the overall management of pediatric surgical anesthesia.
Detailed description
Participants will be randomly allocated to three groups: remimazolam group(Group A), dexmedetomidine group(Group B), esketamine group(Group C). Before entering the operating room, an intravenous access is established. Under the accompaniment of a parent, one of the three drugs is administered intravenously.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg | Experimental | Drug: remimazolam groupRemimazolam is administered intravenously at a dose of 0.3 mg/kg |
| dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kg | Active comparator | Drug: dexmedetomidine groupdexmedetomidine is administered intravenously at a dose of 1 μg/kg |
| esketamine group: esketamine is administered intravenously at a dose of 0.5 mg/kg | Active comparator | Drug: esketamine groupesketamine is administered intravenously at a dose of 0.5 mg/kg |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2 to 5 years old
- the American Society of Anesthesiologists (ASA) physical status of Class I
- scheduled for adenotonsillectomy under general anesthesia, will be included.
Key exclusion criteria (4 listed)
- Abnormal lung function and respiratory system function
- airway obstruction or deformity, history of mental illness
- electrocardiogram indicating bradycardia
- history of cardiac disease
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 |
|---|---|---|
| remimazolam groupAlso: remimazolamremimazolam is administered intravenously at a dose of 0.3 mg/kg | Drug | Remimazolam group: Remimazolam is administered intravenously at a dose of 0.3 mg/kg |
| dexmedetomidine groupAlso: dexmedetomidinedexmedetomidine is administered intravenously at a dose of 1 μg/kg | Drug | dexmedetomidine group: dexmedetomidine is administered intravenously at a dose of 1 μg/kg |
| esketamine groupAlso: esketamineesketamine is administered intravenously at a dose of 0.5 mg/kg | Drug | esketamine group: esketamine is administered intravenously at a dose of 0.5 mg/kg |
Primary outcome
Sedation success rate
Time frame: 0, 3, 5, 10 minutes after the drug injection
1 points represents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls. If the Ramasay score greater than 2 points, it is considered a successful sedation.
Onset time of sedation
Time frame: 0, 3, 5, 10 minutes after the drug injection
The time from the end of drug injection until the Ramsay score is greater than 2 points. If the Ramasay score greater than 2 points, it is considered a successful sedation. 1 points of ramasay scorere presents the child being restless and irritable; 2 points represents that the child is quiet and cooperative; 3 points represents that the child is drowsy and able to obey instructions; A score of 4 indicates that the child is in a shallow sleep state and can be quickly awakened; 5 points represent the child falling asleep and having a slow response to calls; 6 points represent the child's deep sleep state and no response to calls.
Parent-Child Separation Anxiety Score (PASA Score)
Time frame: 0, 3, 5, 10 minute after the drug injection
if the PASA score is greater than 2, it is considered a positive reaction to separation anxiety. 1 point represents that the child is easily separated from their parents；A score of 2 indicates that the child has crying sounds, easily comforted, and does not rely on their parents；A score of 3 indicates that the child is crying and cannot be comforted, but does not rely on their parents；4 points represent the child crying and relying on their parents
7 secondary outcomes
Mask Acceptance Score (MAS)
Time frame: 0, 3, 5, 10 minutes after the drug injection
incidence of adverse reactions
Time frame: during intravenous bolus administration of sedative drugs and anesthesia induction
restlessness rating scale for awakening period(PAED)
Time frame: 0, 5, 10, 20 minutes after the patient awake
Heart rate
Time frame: 0, 3, 5, and 10 minutes after the drug injection
blood pressure
Time frame: 0,3,5,10 minute after drug injectuion
respiratory rate
Time frame: 0,3,5,10 minute after drug injectuion
pulse oximetry saturation
Time frame: 0,3,5,10 minute after drug injectuion
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 10 Jul 2025.
- Individual participant dataSharing planned: Yes. I plan to share IPD after the end of this study, including the study protocol, informed consent form and clinical study report.
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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.
Na Li NaLi, MD principal investigator
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam group, dexmedetomidine group and esketamine group in people with Remimazolam and Dexmedetomidine, run by Maternal and Child Health Hospital of Hubei Province at 1 site 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 10 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 NaLi, MD (+862763490107, lina@hbfy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation success rate (time frame: 0, 3, 5, 10 minutes after the drug injection). The study lists 3 primary outcomes in all. 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 10 Jul 2025.