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

Phase 1CompletedNCT04200235

Jiangsu HengRui Medicine Co., Ltd.48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Preoperative Sedation

Interventions

Dexmedetomidine hydrochloride nasal sprayDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing children's hospital, capital medical university

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

PK Cmax

Maximum blood concentration (Cmax)

Time frame: 0 to 1 hour after administration

Secondary Outcomes

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.

Time frame: 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;

Time frame: 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;

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

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 opioid analgesic(μg) during general anesthesia

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

Time of anesthesia awakening

Data from ClinicalTrials.gov

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