Clinical trial NCT04383418: A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults
Official title: Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Preoperative Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dexmedetomidine hydrochloride nasal spray compared with placebo
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Total consumption of propofol during bispectral index reaches 60 for the first time
timeFrame: The bispectral index reaches 60 for the first time during intraoperative
measure: Total consumption of propofol during general anesthesia
timeFrame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
measure: Total consumption of opioid analgesic during bispectral index reaches 60 for the first time
timeFrame: The bispectral index reaches 60 for the first time during intraoperative
measure: Total consumption of opioid analgesic during general anesthesia
timeFrame: From the beginning of anesthesia to the end of surgical operation up to 4 hours
measure: The BIS value for the Ramsay sedation score of 3 for the first time after administration
timeFrame: The Ramsay sedation score of 3 for the first time during intraoperative
measure: Anesthesiologist satisfaction rating
timeFrame: At the end of surgery when the patient recovers from anesthesia
measure: Subjects' satisfaction rating
timeFrame: From the end of surgical operation up to 24 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Fudan University, Shanghai
name: Changhong Miao, PhD
role: PRINCIPAL_INVESTIGATOR
References: