NCT04720963

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

February 7, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

January 11, 2021

Last Update Submit

September 6, 2023

Conditions

Sedative; Anxiety Disorder

Keywords

remimazolam

Outcome Measures

Primary Outcomes (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.

    up to 30 minutes after study drug given

Secondary Outcomes (8)

  • The level of sedation

    up to 30 minutes after study drug given

  • the compliance of study drug given

    up to 30 minutes before anesthesia induction

  • Parental separation anxiety scale

    up to 30 minutes after study drug given

  • The degree of cooperation during inhalation anesthesia induction

    intraoperative, (During inhalation anesthesia induction)

  • Mask acceptance scale，MAS

    intraoperative, (During inhalation anesthesia induction)

  • +3 more secondary outcomes

Study Arms (3)

group P (Placebo group)

PLACEBO COMPARATOR

intranasal placebo about 30min before anesthesia induction

Other: Distilled water for injection

group R (remimazolam group)

EXPERIMENTAL

intranasal remimazolam about 30min before anesthesia induction

Drug: Remimazolam

group D (Dexmedetomine group)

ACTIVE COMPARATOR

intranasal dexmedetomidine about 30min before anesthesia induction

Drug: Dexmedetomidine

Interventions

RemimazolamDRUG

intranasal remimazolam

group R (remimazolam group)
Distilled water for injectionOTHER

intranasal distilled water for injection

group P (Placebo group)
DexmedetomidineDRUG

Intranasal dexmedetomidine

group D (Dexmedetomine group)

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wenzhou, Zhejiang, China

Location

Related Publications (1)

  • 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.

    PMID: 38774484DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

remimazolamInjectionsDexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Huacheng Liu

    Second Affiliated Hospital of Wenzhou Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 22, 2021

Study Start

February 7, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)