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

Preoperative Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04200235
• Other study ID #: HR0171401-102
• Status: Completed
• Phase: Phase 1
• Start date: January 6, 2020
• Est. completion date: August 7, 2020

Study information

• Verified date: November 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 7, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Preoperative Sedation

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing children's hospital, capital medical university	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK Cmax	Maximum blood concentration (Cmax)	0 to 1 hour after administration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of anesthesia awakening	Time of anesthesia awakening	Up to 4 hours after the end of surgical operation
Secondary	Proportion of subjects with postoperative agitation	Proportion of subjects with postoperative agitation	Up to 4 hours after the end of surgical operation