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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Experimental | In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray. |
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| Low dose group | Experimental | In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray. |
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| Placebo group | Placebo Comparator | In the placebo group,36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine nasal spray | Drug | dexmedetomidine nasal spray |
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| 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
| 0 minute to 45 minutes after administration |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changhong Miao, PhD | Zhongshan Hospital, Fudan University, Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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Dexmedetomidine hydrochloride nasal spray compared with placebo
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| dexmedetomidine hydrochloride nasal spray blank preparation | Drug | dexmedetomidine hydrochloride nasal spray blank preparation |
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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 |