Preoperative SedationPhase 3NCT04383418
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Adults
A Phase 3 study testing dexmedetomidine hydrochloride nasal spray and dexmedetomidine hydrochloride nasal spray blank preparation in people with Preoperative Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Preoperative Sedation
- What is being tested?
- dexmedetomidine hydrochloride nasal spray and dexmedetomidine hydrochloride nasal spray blank preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2020to 2 Jun 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Scheduled for elective abdominal surgery (excluding hepatic surgery) under general anesthesia, with an expected operative duration of 1-4 hours 3. Male or female adults aged between 18 and 65 years，
- 4. Meet the weight standard：18.5 kg/m²≤BMI≤30 kg/m² 5. Conform to the ASA Physical Status Classification：classification I II.
Who cannot join
- Not suitable for nasal spray
- Having received general anesthesia within 28 days prior to randomization
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with heart rate<60beats/min at screening, or a history of severe arrhythmia such as second degree type II or higher atrioventricular block, or a history of cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with poor blood pressure control after medication
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- 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：Phase 1: Subjects who have received α2-adrenergic receptor agonists or antagonists within 14 days prior to randomization.
- Phase 2: Subjects who have received selective α2-adrenergic receptor agonists or antagonists within 14 days prior to randomization;
- Uncontrolled hepatic or renal dysfunction
- Thyroid dysfunction
- Allergic to a drug ingredient or component
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Preoperative Sedation
- Being tested
- dexmedetomidine hydrochloride nasal spray, dexmedetomidine hydrochloride nasal spray blank preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine hydrochloride nasal sprayDrug
dexmedetomidine hydrochloride nasal spray
dexmedetomidine hydrochloride nasal spray blank preparationDrug
dexmedetomidine hydrochloride nasal spray blank preparation
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | In this group, subjects received a higher dose of dexmedetomidine hydrochloride nasal spray. Receives: Drug: dexmedetomidine hydrochloride nasal spray |
| Low dose group | Experimental | In this group, subjects received a lower dose of dexmedetomidine hydrochloride nasal spray Receives: Drug: dexmedetomidine hydrochloride nasal spray |
| Placebo group | Placebo comparator | In the placebo group, subjects received dexmedetomidine hydrochloride nasal spray blank preparation. Receives: Drug: dexmedetomidine hydrochloride nasal spray blank preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who attained a Ramsay Sedation Score ≥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
Measured: 0 minutes to 45 minutes after administration
Safety Endpoints : Incidence and severity of adverse events
Measured: Within 2 days after study drug administration
Secondary outcomes (11)
Stage I : Propofol infusion rate (mg/kg/h) from the initiation of anesthetic induction until the first time BIS value ≤60 is achieved
Measured: The BIS value reaches 60 for the first time during intraoperative
Stage I : Propofol infusion rate (mg/kg/h) during general anesthesia
Measured: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Stage I : Opioid analgesic infusion rate (μg/kg/min) from the initiation of anesthetic induction until the first time BIS value ≤60 is achieved
Measured: The BIS value reaches 60 for the first time during intraoperative
Stage I : Opioid analgesic infusion rate (μg/kg/min) during general anesthesia
Measured: From the beginning of anesthesia to the end of surgical operation up to 4 hours
Stage I : The BIS value at the time when Ramsay Sedation Score first reaches ≥3 after study drug administration
Measured: The Ramsay Sedation Score ≥3 for the first time during intraoperative
Stage I : 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.
Measured: At the end of surgery when the patient recovers from anesthesia
Stage I : 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.
Measured: From the end of surgical operation up to 24 hours
Stage II: Total dose of propofol (mg/kg) administered from anesthesia induction to achieve a BIS value ≤60
Measured: The BIS value reaches 60 for the first time during intraoperative
Stage II: Changes in BIS value from baseline at 15, 30, and 45 minutes after study drug administration.
Measured: 15, 30, and 45 minutes after study drug administration
Stage II: 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
Measured: At the end of surgery when the patient recovers from anesthesia
Stage II: Time from the start of study drug administration to the first achievement of Ramsay Sedation Score ≥3
Measured: From administration to the beginning of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start31 May 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative SedationStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dexmedetomidine hydrochloride nasal spray compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changhong Miao, PhD, Principal investigator, Zhongshan Hospital, Fudan University, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383418
- Sponsor's protocol ID
- HR0171401-301
- Status last verified
- Oct 2026
- First submitted
- 6 May 2020
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No