A Phase 1 interventional study of Dexmedetomidine hydrochloride nasal spray and Dexmedetomidine hydrochloride nasal spray blank preparation. in Preoperative Sedation, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment
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
Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
High weight group
Drug: Dexmedetomidine hydrochloride nasal spray · Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.
Low weight group
Drug: Dexmedetomidine hydrochloride nasal spray · Drug: Dexmedetomidine hydrochloride nasal spray blank preparation.
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.
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.
Also known as: Placebo
PK Cmax
Maximum blood concentration (Cmax)
Time frame: 0 to 1 hour after administration
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.
Time frame: 0 minute to 45 minutes after administration: every 15 minutes after administration
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;
Time frame: 0 minute to 45 minutes after administration: every 5 minutes after administration
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;
Time frame: 0 minute to 45 minutes after administration: every 5 minutes after administration
Total consumption of propofol(mg) during general anesthesia
Total consumption of propofol(mg) during general anesthesia
Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Total consumption of opioid analgesic(μg) during general anesthesia
Total consumption of opioid analgesic(μg) during general anesthesia
Time frame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Time of anesthesia awakening
Time of anesthesia awakening
Time frame: Up to 4 hours after the end of surgical operation
Proportion of subjects with postoperative agitation
Proportion of subjects with postoperative agitation
Time frame: Up to 4 hours after the end of surgical operation
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Jiangsu HengRui Medicine Co., Ltd.