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

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

Study Overview

• Status: Completed
• Conditions: Preoperative Sedation
• Intervention / Treatment: Drug: Dexmedetomidine hydrochloride nasal spray; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital, 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 were randomized
4. Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
5. Subjects with previous abnormal behavior after medication
6. Subjects with cardiovascular disease
7. Clinically significant abnormal clinical laboratory test value
8. Subjects whose hemoglobin is below the lower limit of normal
9. Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
10. Participated in clinical trials of other drugs before screening (accepted experimental drugs)
11. A history or possibility of difficult airway
12. History of hypersensitivity to drug ingredients or components
13. 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: High weight group	Drug: Dexmedetomidine hydrochloride nasal spray; 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.; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.; 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
Experimental: Low weight group	Drug: Dexmedetomidine hydrochloride nasal spray; 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.; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Cmax	Maximum blood concentration (Cmax)	0 to 1 hour after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who parent-child separation successful	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.	0 minute to 45 minutes after administration: every 15 minutes after administration
Proportion of subjects who the Ramsay score is satisfactory at least once	Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4;	0 minute to 45 minutes after administration: every 5 minutes after administration
Proportion of subjects who the UMSS Scale is satisfactory at least once	Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6;	0 minute to 45 minutes after administration: every 5 minutes after administration
Total consumption of propofol(mg) during general anesthesia	Total consumption of propofol(mg) during general anesthesia	From the beginning of anesthesia to the end of surgical operation up to 4 hours
Total consumption of opioid analgesic(μg) during general anesthesia	Total consumption of opioid analgesic(μg) during general anesthesia	From the beginning of anesthesia to the end of surgical operation up to 4 hours
Time of anesthesia awakening	Time of anesthesia awakening	Up to 4 hours after the end of surgical operation
Proportion of subjects with postoperative agitation	Proportion of subjects with postoperative agitation	Up to 4 hours after the end of surgical operation

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): August 6, 2020
• Study Completion (Actual): August 7, 2020

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: November 1, 2019

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: HR0171401-102

Drug and device information, study documents

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