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Completed

NCT Number: NCT04200235

A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children

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Key information

Conditions

Preoperative Sedation

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing children's hospital, capital medical university

Beijing, Beijing Municipality, 100045, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to provide a written informed consent
  • Male or female
  • Subjects requiring elective general anesthesia surgery
  • Conform to the ASA Physical Status Classification
  • Meet the weight standard

Exclusion criteria

  • Not suitable for nasal spray
  • Pediatric populations requiring special care or court/social welfare supervision
  • Subjects who had been under general anesthesia were randomized
  • Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
  • Subjects with previous abnormal behavior after medication
  • Subjects with cardiovascular disease
  • Clinically significant abnormal clinical laboratory test value
  • Subjects whose hemoglobin is below the lower limit of normal
  • Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
  • Participated in clinical trials of other drugs before screening (accepted experimental drugs)
  • A history or possibility of difficult airway
  • History of hypersensitivity to drug ingredients or components
  • Other circumstances that the investigator judged inappropriate for participation in this clinical trial

Treatment and study plan

Dexmedetomidine hydrochloride nasal spray

Drug

In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray.

In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray.

Dexmedetomidine hydrochloride nasal spray blank preparation.

Drug

In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.

In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.

Other names: Placebo

Primary outcomes

  1. PK Cmax

    Time frame: 0 to 1 hour after administration

    Maximum blood concentration (Cmax)

Secondary outcomes

  1. Proportion of subjects who parent-child separation successful

    Time frame: 0 minute to 45 minutes after administration: every 15 minutes after administration

    The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success defined as a scale of 3 or 4 per item.

  2. Proportion of subjects who the Ramsay score is satisfactory at least once

    Time frame: 0 minute to 45 minutes after administration: every 5 minutes after administration

    Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4;

  3. Proportion of subjects who the UMSS Scale is satisfactory at least once

    Time frame: 0 minute to 45 minutes after administration: every 5 minutes after administration

    Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6;

  4. Total consumption of propofol(mg) during general anesthesia

    Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours

    Total consumption of propofol(mg) during general anesthesia

  5. Total consumption of opioid analgesic(μg) during general anesthesia

    Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours

    Total consumption of opioid analgesic(μg) during general anesthesia

  6. Time of anesthesia awakening

    Time frame: Up to 4 hours after the end of surgical operation

    Time of anesthesia awakening

  7. Proportion of subjects with postoperative agitation

    Time frame: Up to 4 hours after the end of surgical operation

    Proportion of subjects with postoperative agitation

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2019
Registry last updated
Sep 9, 2020

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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