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

NCT04383418 | Unknown Phase 2

• 1 other identifier: HR0171401-301
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Sedation

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes

  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

  0 minute to 45 minutes after administration

Secondary Outcomes (7)

• 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

  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

  The bispectral index reaches 60 for the first time during intraoperative

• 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 Ramsay sedation score of 3 for the first time during intraoperative

Study Arms (3)

High dose group

EXPERIMENTAL

In the low dose group, 36 subjects will receive a low dose of dexmedetomidine nasal spray.

Drug: dexmedetomidine nasal spray

Low dose group

EXPERIMENTAL

In the high dose group, 36 subjects will receive a high dose of dexmedetomidine nasal spray.

Drug: dexmedetomidine nasal spray

Placebo group

PLACEBO COMPARATOR

In the placebo group，36 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.

Drug: dexmedetomidine hydrochloride nasal spray blank preparation

Interventions

dexmedetomidine nasal spray DRUG

dexmedetomidine nasal spray

High dose group; Low dose group

dexmedetomidine hydrochloride nasal spray blank preparation DRUG

dexmedetomidine hydrochloride nasal spray blank preparation

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring elective general anesthesia surgery
• Male or female
• Meet the weight standard
• Conform to the ASA Physical Status Classification

You may not qualify if:

• Not suitable for nasal spray
• Subjects who had received general anesthesia
• Subjects with a history of myocardial infarction or unstable angina pectoris
• Subjects with atrioventricular block or cardiac insufficiency
• Subjects with a history of ischemic stroke or transient ischemic attack
• Subjects with poor blood pressure control after medication
• Subjects with abnormal clotting function
• Subjects with a history of mental illness and a history of cognitive impairment epilepsy
• Subjects with a history or possibility of a difficult airway
• Subject with a history of substance abuse and drug abuse
• Adrenoceptor agonists or antagonists were used before randomization
• Abnormal values in the laboratory
• Thyroid dysfunction
• Allergic to a drug ingredient or component
• Pregnant or nursing women

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Study Officials

• Changhong Miao, PhD

  Zhongshan Hospital, Fudan University, Shanghai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dexmedetomidine hydrochloride nasal spray compared with placebo

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 12, 2020
• Study Start: May 31, 2020
• Primary Completion: June 2, 2021
• Study Completion: September 10, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

CN (1)