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

Phase 3

Completed

• Conditions: Preoperative Sedation of Children
• Interventions: Drug: Dexmedetomidine hydrochloride nasal spray blank preparation; Drug: Dexmedetomidine Hydrochloride Nasal Spray

• Registration Number: NCT05111431
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-08
• Study Start: 2021-11-24
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine hydrochloride nasal spray blank preparation	Dexmedetomidine hydrochloride nasal spray blank preparation	-
Dexmedetomidine Hydrochloride Nasal Spray	Dexmedetomidine Hydrochloride Nasal Spray	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Beijing Children's Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China