UnknownPhase 2/3

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

China201 participantsStarted 2020-05-31

Plain-language summary

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults. To explore the reasonable dosage of dexmedetomidine hydrochloride nasal spray for preoperative sedation.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Able and willing to provide a written informed consent
✓. Subjects requiring elective general anesthesia surgery
✓. Male or female
✓. Meet the weight standard
✓. Conform to the ASA Physical Status Classification

Exclusion criteria

✕. Not suitable for nasal spray
✕. Subjects who had received general anesthesia
✕. Subjects with a history of myocardial infarction or unstable angina pectoris
✕. Subjects with atrioventricular block or cardiac insufficiency
✕. Subjects with a history of ischemic stroke or transient ischemic attack
✕. Subjects with poor blood pressure control after medication
✕. Subjects with abnormal clotting function
✕. Subjects with a history of mental illness and a history of cognitive impairment epilepsy

What they're measuring

Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes

Timeframe: 0 minute to 45 minutes after administration

Trial details

NCT IDNCT04383418

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-02

View on ClinicalTrials.gov More Preoperative Sedation trials