AzTrials
AzTrials

Sedative; Anxiety DisorderPhase 4NCT04720963

Intranasal Remimazolam for Premedication in Pediatric Patient

A Phase 4 study testing Remimazolam, Distilled water for injection and Dexmedetomidine in people with Sedative; Anxiety Disorder, 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
Search all trials

Trial summary

Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for pediatric anesthesiologists on how to decrease anxiety for children in the operating room (OR) environment and to… Read more about this study

Who is it for?
Ages 2 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Sedative; Anxiety Disorder
What is being tested?
Remimazolam, Distilled water for injection and Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
7 Feb 2021to 28 Feb 2022
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 2 to 5 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 2-5 years；
  • children with weight for age within the normal range
  • were scheduled surgery with general anesthesia

Who cannot join

  • Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
  • contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or remimazolam;
  • with any nasal pathology,organ dysfunction;
  • 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: Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial

Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for pediatric anesthesiologists on how to decrease anxiety for children in the operating room (OR) environment and to facilitate a smooth induction of anesthesia. Various factors like parental separation, unfamiliar surroundings, fear of physicians and needle injections can increase their preoperative anxiety. The researchers conducted the current study to investigate whether intranasal remimazolam can reduce anxiety in children before surgery.

Read the detailed description

children aged 2-5 years old were randomly allocated into three equal groups based on the premedication routes: Group R with intranasal remimazolam, Group D with intranasal dexmedetomidine and Group P with intranasal placebo, respectively.

Being tested
Remimazolam, Distilled water for injection, Dexmedetomidine
Keywords
remimazolam
Medical subject headings
Anxiety Disorders

What participants receive

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

  • RemimazolamDrug

    intranasal remimazolam

  • Distilled water for injectionOther

    intranasal distilled water for injection

  • DexmedetomidineDrug

    Intranasal dexmedetomidine

Study groups in NCT04720963
Study groupRoleWhat they receive
group P (Placebo group)Placebo comparatorintranasal placebo about 30min before anesthesia induction
Receives: Other: Distilled water for injection
group R (remimazolam group)Experimentalintranasal remimazolam about 30min before anesthesia induction
Receives: Drug: Remimazolam
group D (Dexmedetomine group)Active comparatorintranasal dexmedetomidine about 30min before anesthesia induction
Receives: Drug: Dexmedetomidine

What is being measured

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

  1. The level of anxiety

    The Modified Yale Preoperative Anxiety Scale:

    The 22-item measure has five behavioural categories: activity, emotional expressivity, alertness and arousal, vocalizations, and interaction with parents. Total scores range from 23.33 through 100 with higher scores indicating greater anxiety.

    Measured: up to 30 minutes after study drug given

Secondary outcomes (8)

  1. The level of sedation

    Ramsay score

    1. Patient anxious or agitated or both
    2. Patient cooperative, oriented and tranquil
    3. Patient responds to commands only
    4. A brisk response to a light glabellar tap
    5. A sluggish response to a light glabellar tap
    6. No response higher scores mean a higher levels of sedation.

    Measured: up to 30 minutes after study drug given

  2. the compliance of study drug given

    behavior score

    1. Clam and cooperative；
    2. Anxious but reassurable;
    3. Anxious but not reassurable;
    4. Crying, or resisting The scores of 1 and 2 signified satisfactory compliance, whereas scores of 3 and 4 were classified as poor compliance.

    Measured: up to 30 minutes before anesthesia induction

  3. Parental separation anxiety scale

    A four-point parental separation anxiety scale as follows:

    1. Easy separation,
    2. Whimpers, but is easily reassured, not clinging,
    3. Cries and cannot be easily reassured, but not clinging to parents,
    4. Crying and clinging to parents. The scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 were classified as difficult separation.

    Measured: up to 30 minutes after study drug given

  4. The degree of cooperation during inhalation anesthesia induction

    Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction

    Measured: intraoperative, (During inhalation anesthesia induction)

  5. Mask acceptance scale，MAS

    Mask acceptance scale，MAS

    1. terrified, crying, agitated
    2. moderate fear, not calmed with reassurance
    3. slight fear of mask, easily calmed
    4. unafraid, cooperative, accepts mask readily The scores of 3 and 4 signified satisfactory mask acceptable whereas scores of 1 and 2 were classified as poor mask acceptable.

    Measured: intraoperative, (During inhalation anesthesia induction)

  6. Pediatric anesthesia emergence delirium scale，PAEDs

    The pediatric anesthesia emergence delirium scale consists of four 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

  7. Recovery times

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

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

  8. 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. Any adverse effects requiring interventions

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

Timeline

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

  1. First posted22 Jan 2021
  2. Study start7 Feb 2021
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04720963
Sponsor's protocol ID
SAHoWMU-CR2020-03-114
Status last verified
Sep 2023
First submitted
11 Jan 2021
Last updated
8 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cai YH, Wang CY, Fang YB, Ma HY, Gao YQ, Wang Z, Wu J, Lin H, Liu HC. Preoperative Anxiolytic and Sedative Effects of Intranasal Remimazolam and Dexmedetomidine: A Randomized Controlled Clinical Study in Children Undergoing General Surgeries. Drug Des Devel Ther. 2024 May 17;18:1613-1625. doi: 10.2147/DDDT.S461122. eCollection 2024.

    PubMed 38774484

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Remimazolam, Distilled water for injection and Dexmedetomidine in people with Sedative; Anxiety Disorder, 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 5 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 8 Sep 2023. 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. 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?

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 level of anxiety (time frame: up to 30 minutes after study drug given). 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 NCT04720963, 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 8 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in