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

Study Overview
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Brief Summary
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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.

Official Title
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Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Adults

Conditions
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Preoperative Sedation

Intervention / Treatment
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* Drug: dexmedetomidine nasal spray
* Drug: dexmedetomidine hydrochloride nasal spray blank preparation


Participation Criteria
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Eligibility Criteria
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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 Subjects with a history or possibility of a difficult airway Subject with a history of substance abuse and drug abuse Adrenoceptor agonists or antagonists were used before randomization Abnormal values in the laboratory Thyroid dysfunction Allergic to a drug ingredient or component Pregnant or nursing women No birth control during the specified period of time Participated in clinical trials of other drugs (received experimental drugs) The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dexmedetomidine hydrochloride nasal spray compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose group<br>In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray. | Drug: dexmedetomidine nasal spray<br>* dexmedetomidine nasal spray<br>|
| Experimental: Low dose group<br>In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray. | Drug: dexmedetomidine nasal spray<br>* dexmedetomidine nasal spray<br>|
| Placebo Comparator: Placebo group<br>In the placebo group，36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. | Drug: dexmedetomidine hydrochloride nasal spray blank preparation<br>* dexmedetomidine hydrochloride nasal spray blank preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes | Evaluated with Ramsay sedation scale Score Response Anxious or restless or both Cooperative, orientated and tranquil Responding to commands Brisk response to stimulus Sluggish response to stimulus No response to stimulus | 0 minute to 45 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of propofol during bispectral index reaches 60 for the first time | Total consumption of propofol during bispectral index reaches 60 for the first time | The bispectral index reaches 60 for the first time during intraoperative | 
| Total consumption of propofol during general anesthesia | Total consumption of propofol during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours | 
| Total consumption of opioid analgesic during bispectral index reaches 60 for the first time | Total consumption of opioid analgesic during bispectral index reaches 60 for the first time | The bispectral index reaches 60 for the first time during intraoperative | 
| Total consumption of opioid analgesic during general anesthesia | Total consumption of opioid analgesic during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours | 
| The BIS value for the Ramsay sedation score of 3 for the first time after administration | The BIS value for the Ramsay sedation score of 3 for the first time after administration | The Ramsay sedation score of 3 for the first time during intraoperative | 
| Anesthesiologist satisfaction rating | The anesthesiologist satisfaction rating is a scale of 0 to 10, satisfaction defined as a scale of 10, dissatisfaction defined as a scale of 0. | At the end of surgery when the patient recovers from anesthesia | 
| Subjects' satisfaction rating | The subjects' satisfaction rating is a scale of 0 to 10, satisfaction defined as a scale of 10, dissatisfaction defined as a scale of 0. | From the end of surgical operation up to 24 hours |