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

Phase 2

• Conditions: Preoperative Sedation
• Interventions: Drug: dexmedetomidine hydrochloride nasal spray blank preparation; Drug: dexmedetomidine nasal spray

• Registration Number: NCT04383418
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Study Start: 2020-05-31
• Primary Completion: 2021-06-02
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15
• Study Completion: 2021-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	dexmedetomidine hydrochloride nasal spray blank preparation	In the placebo group，36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
High dose group	dexmedetomidine nasal spray	In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray.
Low dose group	dexmedetomidine nasal spray	In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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.
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
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
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
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.

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China