Intranasal Remimazolam for Premedication in Pediatric Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-07

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sedative; Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group P (Placebo group)

intranasal placebo about 30min before anesthesia induction

Group Type PLACEBO_COMPARATOR

Distilled water for injection

Intervention Type OTHER

intranasal distilled water for injection

group R (remimazolam group)

intranasal remimazolam about 30min before anesthesia induction

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

intranasal remimazolam

group D (Dexmedetomine group)

intranasal dexmedetomidine about 30min before anesthesia induction

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Intranasal dexmedetomidine

Interventions

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Remimazolam

intranasal remimazolam

Intervention Type DRUG

Distilled water for injection

intranasal distilled water for injection

Intervention Type OTHER

Dexmedetomidine

Intranasal dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 2-5 years；
3. children with weight for age within the normal range
4. were scheduled surgery with general anesthesia

Exclusion Criteria

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either dexmedetomidine or remimazolam;
3. with any nasal pathology,organ dysfunction;
4. recently respiratory infection, mental disorder;
5. other reasons that researchers hold it is not appropriate to participate in this trial.-

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes