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PediatricPhase 4NCT06061159

The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction

A Phase 4 study testing Remimazolam besylate in people with Pediatric and ED95, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of the surgery.Propofol is often used for anesthesia induction in clinical work, which can achieve good anesthesia effects. Read more about this study

Who is it for?
Ages 1 year to 12 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric, ED95, Sedation
What is being tested?
Remimazolam besylate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
6 Oct 2023to 27 Feb 2024
Phase
Phase 4
Are there results?
None posted in the registry

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 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • with American Society of Anesthesiologists (ASA) physical status I or II；
  • aged 1-12 years；
  • children with weight for age within the normal range；
  • were scheduled general anesthesia surgery

Who cannot join

  • Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
  • contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam;
  • recently respiratory infection, mental disorder;
  • other reasons that researchers hold it is not appropriate to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

Other trials in China

About this study

Official title: The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction:a Randomised,Double-blind Clinical Trial

Due to the incomplete development of systems and low pain thresholds in the pediatric population, good general anesthesia is required during the perioperative period to ensure the smooth progress of the surgery.Propofol is often used for anesthesia induction in clinical work, which can achieve good anesthesia effects. However, this drug has obvious injection pain and is prone to significant inhibition of blood circulation, and may even lead to adverse conditions such as respiratory depression in children. For the pediatric population, maintaining appropriate anesthesia depth and stable circulation during the induction period of general anesthesia has always been a focus of attention and research by anesthesiologists.Remimazolam besylate is a new type of water-soluble ultra short acting benzodiazepine drug that is hydrolyzed and metabolized by plasma esterase in the body, independent of liver and kidney function, and the metabolite zolam propionic acid has no pharmacological activity; Rapid onset and failure, short sedation recovery time; Has little impact on respiration and circulation; And there is no injection pain.Remazolam besylate is highly suitable for children due to its characteristics, and some studies have demonstrated the safety of intravenous injection of Remazolam besylate. However, there is limited research on its dosage exploration, which to some extent limits its clinical application in children.This study aims to explore the 95% effective dose (ED95) of single intravenous injection of remidazolam besylate in children of different age groups, providing a theoretical basis for the use of remidazolam besylate in pediatric anesthesia.

Read the detailed description

This experiment was divided into three groups based on the age of the children, namely 1-3 years old, 4-6 years old, 7-12 years old, with an initial dose of 0.2mg/kg. The time of consciousness loss in the children was evaluated after injection of ramazolam besylate to determine whether sedation had been achieved. The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the ED95 of a single intravenous injection of ramazolam in children of different age groups.

Being tested
Remimazolam besylate
Keywords
remimazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remimazolam besylateDrug

    Also called single intravenous bolus remimazolam according to biased coin design

    initial dose is 0.2mg/kg；adjust dosage is 0.05mg/kg

  • Remimazolam besylateDrug

    Also called single intravenous bolus remimazolam according to biased coin design

    initial dose is based on the findings from the school-age group；adjust dosage is 0.05mg/kg

Study groups in NCT06061159
Study groupRoleWhat they receive
1-3years oldExperimentalsingle intravenous bolus remimazolam about 5min before general anesthesia induction
Receives: Drug: Remimazolam besylate
3-6years oldExperimentalsingle intravenous bolus remimazolam about 5min before general anesthesia induction
Receives: Drug: Remimazolam besylate
6-12years oldExperimentalsingle intravenous bolus remimazolam about 5min before general anesthesia induction
Receives: Drug: Remimazolam besylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the time of the loss of consciousness(LOC)

    Modified Observers Assessment of Alertness/Sedation (MOAA/S) score of 1 or deeper within 1 minute, and maintained until the end of the 5-minute observation period.

    Measured: during anaesthetic induction

Secondary outcomes (5)

  1. Modified observer's assessment of alertness／sedation（MOAA/S）scale

    5-Subject responds readily to name spoken in a normal tone; 4 -Lethargic response of a subject to a name spoken in a normal tone; 3 -The subject responds only after a name is called loudly and repeatedly; 2 -The subject responds only after mild prodding or shaking;

    1 -The subject responds only after a painful trapezius squeeze; 0 -The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 1 points represent successful sedation

    Measured: Every 1 minutes after single intravenous bolus remimazolam

  2. BIS

    BIS values range from 0 to 100. A value of 0 represents the absence of brain activity, and 100 represents the awake state.

    BIS values between 60 to 80 represent sedation; BIS values between 40 to 60 represent adequate general anesthesia for a surgery; values less than 40 represent a deep hypnotic state.

    Measured: Every 1 minutes after single intravenous bolus remimazolam

  3. Recovery time

    The time from discontinuation of sevoflurane to the first open eye of the children and to achieve the modified aldrete scole ≥9.

    then the aldrete scole's minimum value is 0 and maximum value is 10, and higher scores mean a better or outcome.

    The modified aldrete scole consists of five items. Each item is scored 0-2 yielding a total between 0 and 10.

    Measured: Within up to 30 minutes after child's first eye opening in the postoperative period

  4. Number of children with adverse effects

    Number of children with adverse effects:

    １、Bradycardia and/or hypotension need for hemodynamic support; 2、Desaturation is defined as Oxygen desaturation <90%; 3、Nausea and vomiting; 4、Any adverse effects requiring interventions.

    Measured: Up to 24 hours including preoperative, intraoperative, and postoperative periods

  5. Rate of Pediatric anesthesia emergence delirium

    The pediatric anesthesia emergence delirium scale consists of five items. Each item is scored 0-4 yielding a total between 0 and 20.

    The degree of emergence delirium increased directly with the total score. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.

    Measured: Within up to 15-30 minutes after child's first eye opening in the postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start6 Oct 2023
  3. Primary completion27 Feb 2024
  4. Study completion27 Feb 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06061159
Sponsor's protocol ID
SAHoWMU-CR2023-03-107
Status last verified
Feb 2025
First submitted
24 Sep 2023
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cai YH, Dong LQ, Zhong JW, Lin Z, Chen CD, Zhu LB, Lin XK, Szmuk P, Liu HC. ED50 and ED95 of remimazolam for loss of consciousness in young children: a dose-finding study for induction of anaesthesia. Br J Anaesth. 2025 Jun;134(6):1709-1716. doi: 10.1016/j.bja.2025.02.004. Epub 2025 Mar 18.

    PubMed 40107902

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Remimazolam besylate in people with Pediatric and ED95, run by Second Affiliated Hospital of Wenzhou Medical University 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 4 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: finished, as of the sponsor's last update on 7 Feb 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the time of the loss of consciousness(LOC) (time frame: during anaesthetic induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06061159, which also lists 1 linked publication.

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 7 Feb 2025.

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