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Completed

NCT Number: NCT05111431

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

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

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Key information

Conditions

Preoperative Sedation of Children

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Children's Hospital Affiliated to 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 when they were randomized
  • Subjects with a history of mental illness and a history of cognitive impairment epilepsy
  • Subjects with cardiovascular disease
  • Subjects whose hemoglobin is below the lower limit of normal
  • Subjects with a history or possibility of a difficult airway
  • Abnormal liver function and/or abnormal renal function
  • Adrenoceptor agonists or antagonists or analgesics were used before randomization
  • Participated in clinical trials (received experimental drugs)
  • 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, the subjects will receive a low dose of dexmedetomidine nasal spray.

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

Dexmedetomidine hydrochloride nasal spray blank preparation

Drug

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

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

Primary outcomes

  1. Proportion of subjects who meet parent-child separation successful

    Time frame: within 45 minutes after the beginning of administration

  2. Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration

    Time frame: within 45 minutes after the beginning of administration

Secondary outcomes

  1. Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration

    Time frame: Within 45 minutes after the beginning of administration

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

  2. Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days

    Time frame: an average of 3 days

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

  3. Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration

    Time frame: Within 45 minutes after the beginning of administration

    Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.

  4. Time from the beginning of administration to the satisfactory Ramsay score for the first time

    Time frame: from the beginning of administration to the first successful Ramsay score

    Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.

  5. Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration

    Time frame: within 45 minutes after the beginning of administration

    Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2 .

  6. Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days

    Time frame: an average of 3 days

    Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2.

  7. Time of anesthesia awakening through study completion，an average of 3 days

    Time frame: an average of 3 days

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2021
Registry last updated
Nov 7, 2022

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.