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

Preoperative Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04383418
• Other study ID #: HR0171401-301
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: May 31, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: July 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: September 10, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Preoperative Sedation

Intervention

Drug:
• dexmedetomidine nasal spray
dexmedetomidine nasal spray
• dexmedetomidine hydrochloride nasal spray blank preparation
dexmedetomidine hydrochloride nasal spray blank preparation

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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