Clinical trial NCT05111431: A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
Official title: Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preoperative Sedation of Children
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 159
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dexmedetomidine hydrochloride nasal spray compared with placebo
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who meet parent-child separation successful
timeFrame: within 45 minutes after the beginning of administration
measure: Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration
timeFrame: within 45 minutes after the beginning of administration
Secondary outcomes:
measure: Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration
timeFrame: Within 45 minutes after the beginning of administration
measure: Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days
timeFrame: an average of 3 days
measure: Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration
timeFrame: Within 45 minutes after the beginning of administration
measure: Time from the beginning of administration to the satisfactory Ramsay score for the first time
timeFrame: from the beginning of administration to the first successful Ramsay score
measure: Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration
timeFrame: within 45 minutes after the beginning of administration
measure: Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days
timeFrame: an average of 3 days
measure: Time of anesthesia awakening through study completion，an average of 3 days
timeFrame: an average of 3 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
References: