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NCT Number: NCT04720963

Intranasal Remimazolam for Premedication in Pediatric Patient

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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Key information

Conditions

Sedative; Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Wenzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.-

Treatment and study plan

Remimazolam

Drug

intranasal remimazolam

Distilled water for injection

Other

intranasal distilled water for injection

Dexmedetomidine

Drug

Intranasal dexmedetomidine

Primary outcomes

  1. The level of anxiety

    Time frame: up to 30 minutes after study drug given

    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.

Secondary outcomes

  1. The level of sedation

    Time frame: up to 30 minutes after study drug given

    Ramsay score

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

  2. the compliance of study drug given

    Time frame: up to 30 minutes before anesthesia induction

    behavior score

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

  3. Parental separation anxiety scale

    Time frame: up to 30 minutes after study drug given

    A four-point parental separation anxiety scale as follows:

    • Easy separation,
    • Whimpers, but is easily reassured, not clinging,
    • Cries and cannot be easily reassured, but not clinging to parents,
    • 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.

  4. The degree of cooperation during inhalation anesthesia induction

    Time frame: intraoperative, (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

  5. Mask acceptance scale，MAS

    Time frame: intraoperative, (During inhalation anesthesia induction)

    Mask acceptance scale，MAS

    • terrified, crying, agitated
    • moderate fear, not calmed with reassurance
    • slight fear of mask, easily calmed
    • 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.

  6. Pediatric anesthesia emergence delirium scale，PAEDs

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

    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.

  7. Recovery times

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

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

  8. Number of children with adverse effects

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

    Number of children with adverse effects

    • Bradycardia and/or hypotension need for hemodynamic support
    • Desaturation is defined as Oxygen desaturation <90%
    • Any adverse effects requiring interventions

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Intranasal Remimazolam for Premedication in Pediatric Patients: a Double-blinded Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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