Preoperative Sedation
Conditions
Brief 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.
Interventions
dexmedetomidine nasal spray
dexmedetomidine hydrochloride nasal spray blank preparation
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Dexmedetomidine hydrochloride nasal spray compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia surgery 3. Male or female 4. Meet the weight standard 5. Conform to the ASA Physical Status Classification
Exclusion criteria
1. Not suitable for nasal spray 2. Subjects who had received general anesthesia 3. Subjects with a history of myocardial infarction or unstable angina pectoris 4. Subjects with atrioventricular block or cardiac insufficiency 5. Subjects with a history of ischemic stroke or transient ischemic attack 6. Subjects with poor blood pressure control after medication 7. Subjects with abnormal clotting function 8. Subjects with a history of mental illness and a history of cognitive impairment epilepsy 9. Subjects with a history or possibility of a difficult airway 10. Subject with a history of substance abuse and drug abuse 11. Adrenoceptor agonists or antagonists were used before randomization 12. Abnormal values in the laboratory 13. Thyroid dysfunction 14. Allergic to a drug ingredient or component 15. Pregnant or nursing women 16. No birth control during the specified period of time 17. Participated in clinical trials of other drugs (received experimental drugs) 18. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes | 0 minute to 45 minutes after administration | Evaluated with Ramsay sedation scale Score Response 1. Anxious or restless or both 2. Cooperative, orientated and tranquil 3. Responding to commands 4. Brisk response to stimulus 5. Sluggish response to stimulus 6. No response to stimulus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 propofol during general anesthesia |
| 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 bispectral index reaches 60 for the first time |
| Total consumption of opioid analgesic during general anesthesia | From the beginning of anesthesia to the end of surgical operation up to 4 hours | Total consumption of opioid analgesic during general anesthesia |
| 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 bispectral index reaches 60 for the first time |
| Anesthesiologist satisfaction rating | At the end of surgery when the patient recovers from anesthesia | 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. |
| Subjects' satisfaction rating | From the end of surgical operation up to 24 hours | 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. |
| 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 | The BIS value for the Ramsay sedation score of 3 for the first time after administration |
Countries
China
Outcome results
None listed