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

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

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

Study Overview

• Status: Completed
• Conditions: Preoperative Sedation of Children
• Intervention / Treatment: Drug: Dexmedetomidine Hydrochloride Nasal Spray; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital Affiliated to Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Male or female
3. Subjects requiring elective general anesthesia surgery
4. Conform to the ASA Physical Status Classification
5. Meet the weight standard

Exclusion Criteria:

1. Not suitable for nasal spray
2. Pediatric populations requiring special care or court/social welfare supervision
3. Subjects who had been under general anesthesia when they were randomized
4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
5. Subjects with cardiovascular disease
6. Subjects whose hemoglobin is below the lower limit of normal
7. Subjects with a history or possibility of a difficult airway
8. Abnormal liver function and/or abnormal renal function
9. Adrenoceptor agonists or antagonists or analgesics were used before randomization
10. Participated in clinical trials (received experimental drugs)
11. History of hypersensitivity to drug ingredients or components
12. Other circumstances that the investigator judged inappropriate for participation in this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine Hydrochloride Nasal Spray	Drug: Dexmedetomidine Hydrochloride Nasal Spray; 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.
Placebo Comparator: Dexmedetomidine hydrochloride nasal spray blank preparation	Drug: Dexmedetomidine hydrochloride nasal spray blank preparation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who meet parent-child separation successful	within 45 minutes after the beginning of administration
Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration	within 45 minutes after the beginning of administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who meet parent-child separation successful 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.	Within 45 minutes after the beginning of administration
Time from the beginning of administration to the successful parent-child separation for the first time through study completion，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.	an average of 3 days
Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration	Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.	Within 45 minutes after the beginning of administration
Time from the beginning of administration to the satisfactory Ramsay score for the first time	Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.	from the beginning of administration to the first successful Ramsay score
Proportion of subjects whose the UMSS Scale is satisfactory at least once 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 .	within 45 minutes after the beginning of administration
Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days	Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2.	an average of 3 days
Time of anesthesia awakening through study completion，an average of 3 days		an average of 3 days

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: HR0171401-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No