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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Preoperative Sedation
• Intervention / Treatment: Drug: dexmedetomidine nasal spray; Drug: dexmedetomidine hydrochloride nasal spray blank preparation

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose group; In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray.	Drug: dexmedetomidine nasal spray; dexmedetomidine nasal spray
Experimental: Low dose group; In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray.	Drug: dexmedetomidine nasal spray; dexmedetomidine nasal spray
Placebo Comparator: Placebo group; In the placebo group，36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.	Drug: dexmedetomidine hydrochloride nasal spray blank preparation; dexmedetomidine hydrochloride nasal spray blank preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; 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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Changhong Miao, PhD, Zhongshan Hospital, Fudan University, Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2020
• Primary Completion (Actual): June 2, 2021
• Study Completion (Anticipated): September 10, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: HR0171401-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No