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

NCT04200235 | Completed Phase 1

• 1 other identifier: HR0171401-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preoperative Sedation

Outcome Measures

Primary Outcomes (1)

• PK Cmax

  Maximum blood concentration (Cmax)

  0 to 1 hour after administration

Secondary Outcomes (7)

• Proportion of subjects who parent-child separation successful

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

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

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

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

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

• 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

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

Study Arms (2)

High weight group

EXPERIMENTAL

High weight group

Drug: Dexmedetomidine hydrochloride nasal spray; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.

Low weight group

EXPERIMENTAL

Low weight group

Drug: Dexmedetomidine hydrochloride nasal spray; Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.

Interventions

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.

High weight group; Low weight group

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.

Also known as: Placebo

High weight group; Low weight group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing children's hospital, capital medical university

Beijing, Beijing Municipality, 100045, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dexmedetomidine hydrochloride nasal spray compared with placebo

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 16, 2019
• Study Start: January 6, 2020
• Primary Completion: August 6, 2020
• Study Completion: August 7, 2020
• Last Updated: September 9, 2020

Record last verified: 2019-11

Locations

CN (1)