Preoperative Sedation of Children
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.
Interventions
In the low weight group, the subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, the subjects will receive a high dose of dexmedetomidine nasal spray.
In the low weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Dexmedetomidine hydrochloride nasal spray compared with placebo
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 | — |
| 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 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. |
Countries
China
Outcome results
None listed