A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
- Conditions
- Preoperative Sedation
- Interventions
- Registration Number
- NCT04200235
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Able and willing to provide a written informed consent
- Male or female
- Subjects requiring elective general anesthesia surgery
- Conform to the ASA Physical Status Classification
- Meet the weight standard
- Not suitable for nasal spray
- Pediatric populations requiring special care or court/social welfare supervision
- Subjects who had been under general anesthesia were randomized
- Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
- Subjects with previous abnormal behavior after medication
- Subjects with cardiovascular disease
- Clinically significant abnormal clinical laboratory test value
- Subjects whose hemoglobin is below the lower limit of normal
- Subjects who have either an adrenergic receptor agonist or an antagonist were randomized
- Participated in clinical trials of other drugs before screening (accepted experimental drugs)
- A history or possibility of difficult airway
- History of hypersensitivity to drug ingredients or components
- 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 Low weight group Dexmedetomidine hydrochloride nasal spray Low weight group High weight group Dexmedetomidine hydrochloride nasal spray blank preparation. High weight group High weight group Dexmedetomidine hydrochloride nasal spray High weight group Low weight group Dexmedetomidine hydrochloride nasal spray blank preparation. Low weight group
- Primary Outcome Measures
Name Time Method PK Cmax 0 to 1 hour after administration Maximum blood concentration (Cmax)
- Secondary Outcome Measures
Name Time Method Proportion of subjects with postoperative agitation Up to 4 hours after the end of surgical operation Proportion of subjects with postoperative agitation
Proportion of subjects who parent-child separation successful 0 minute to 45 minutes after administration: every 15 minutes after administration 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.
Total consumption of propofol(mg) during general anesthesia From the beginning of anesthesia to the end of surgical operation up to 4 hours Total consumption of propofol(mg) during general anesthesia
Proportion of subjects who the Ramsay score is satisfactory at least once 0 minute to 45 minutes after administration: every 5 minutes after administration Sedation level using the Ramsay scale. Ramsay Satisfaction defined as a scale of 2, 3, or 4;
Total consumption of opioid analgesic(μg) during general anesthesia From the beginning of anesthesia to the end of surgical operation up to 4 hours Total consumption of opioid analgesic(μg) during general anesthesia
Proportion of subjects who the UMSS Scale is satisfactory at least once 0 minute to 45 minutes after administration: every 5 minutes after administration Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction defined as a scale of 3, 4, 5, or 6;
Time of anesthesia awakening Up to 4 hours after the end of surgical operation Time of anesthesia awakening
Trial Locations
- Locations (1)
Beijing children's hospital, capital medical university
🇨🇳Beijing, Beijing, China