DexmedetomidinePhase 4NCT07298525
Safety Exploration and Evaluation of Dexmedetomidine Hydrochloride Nasal Spray for Pre-anesthesia Sedation in Low-Monitoring Settings
A Phase 4 study testing Dexmedetomidine hydrochloride nasal spray in people with Dexmedetomidine and Sedation, run by Sichuan Provincial People's Hospital.
Trial summary
The goal of this clinical trial is to assess the viability of dexmedetomidine hydrochloride nasal spray under minimal or no supervision and to further investigate novel clinical applications for this medication. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, Sedation, Safety
- What is being tested?
- Dexmedetomidine hydrochloride nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 18 years of age or older, including the age of 18; no gender limitation;
- American Society of Anesthesiologists (ASA) grade I to III;
- Require general anesthesia, intraspinal anesthesia, or nerve block anesthesia for an elective surgical procedure;
- Provide informed consent for participation in this study prior to the commencement of the trial and execute a written document of informed consent willingly.
Who cannot join
- Individuals with a known hypersensitivity to dexmedetomidine hydrochloride or any excipient; patients with a documented allergy to any tranquilizers, opioids, or other substances employed in the trial;
- Individuals with airway hyperactivity, such as those suffering from chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea, who are determined by the researchers to have experienced or are experiencing safety concerns related to these conditions;
- Patients with a history of nasal disorders, previous surgical procedures, or allergic reactions deemed clinically significant by the research team, which could significantly impact drug absorption (e.g., chronic nasal congestion, rhinorrhea, nosebleeds, and other symptoms, as well as anatomical or mucosal abnormalities in the nose that may affect drug uptake);
- A blood oxygen saturation (SpO2) level of less than or equal to 92% in a non-oxygenated state during the screening period;
- patients with current psychiatric disorders (like schizophrenia or depression) or cognitive impairment; those with a history of epilepsy; or individuals with a past record of psychotropic or narcotic substance abuse;
- A history of myocardial infarction or unstable angina pectoris within the past six months prior to the screening phase;
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- A heart rate or pulse rate of less than or equal to 50 beats per minute during the screening period, the presence of clinically significant heart functional abnormalities as determined by the investigators, or the presence of grade II or higher atrioventricular block (excluding patients with implanted pacemakers) along with other severe arrhythmias;
- Patients with inadequately controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during the screening period) or hypotension (systolic blood pressure ≤90 mmHg and/or diastolic blood pressure ≤ mmHg during the screening period);
- Participants who have already engaged in other clinical trials and have taken the investigational drug within the three months preceding the screening period;
- Pregnant or lactating women expected to undergo a cesarean section during labor and delivery;
- The investigator concludes that the patient possesses other conditions rendering them ineligible for trial participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to assess the viability of dexmedetomidine hydrochloride nasal spray under minimal or no supervision and to further investigate novel clinical applications for this medication. This study aims to investigate the following aspects: the incidence of adverse respiratory and circulatory events requiring medical intervention following the administration of dexmedetomidine nasal spray for pre-anesthetic sedation, its sedative efficacy and onset time, and its impact on the quality of post-anesthesia recovery and the occurrence of postoperative delirium. Researchers will compare dexmedetomidine hydrochloride nasal spray to a placebo (a look-alike substance that contains no drug) to see the incidence and severity of adverse events following administration. Participants will receive either dexmedetomidine nasal spray or a placebo 45 minutes before anesthesia induction. The blinded assessor will continuously monitor and record vital signs, adverse events, and the level of sedation. More importantly, observations and records should be made for respiratory and circulatory events that require medical intervention. A follow-up assessment will be conducted within three days after the operation to evaluate the incidence of postoperative delirium and patient satisfaction.
- Being tested
- Dexmedetomidine hydrochloride nasal spray, Placebo
- Keywords
- Dexmedetomidine, Sedation, Safety, Preanesthetic Medication, Monitored Anaesthesia Care, Adverse Events of Respiratory Circulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine hydrochloride nasal sprayDrug
Group 1 (LD) was administered 50 μg of dexmedetomidine hydrochloride nasal spray and 50 μg of placebo nasal spray
PlaceboDrug
Group 3 (C) was administered 100 μg of placebo nasal spray
Dexmedetomidine hydrochloride nasal sprayDrug
Group 2 (HD) was administered 100 μg of dexmedetomidine hydrochloride nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Group 1(LD): Dexmedetomidine hydrochloride nasal spray 50μg, and placebo nasal spray 50μg | Experimental | Not described Receives: Drug: Dexmedetomidine hydrochloride nasal spray |
| Group 2(HD): Dexmedetomidine hydrochloride nasal spray 100μg | Experimental | Not described Receives: Drug: Dexmedetomidine hydrochloride nasal spray |
| Group 3(C): Placebo nasal spray 100μg | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events in the circulatory and respiratory system requiring medical intervention
Measured: 45 minutes after administration, before the induction of anesthesia
Secondary outcomes (5)
Ramsay score
The Ramsay Sedation Scale is a widely used tool to assess the level of sedation in patients; a higher level indicates a stronger sedative effect.
Level 1 : Anxiety, with agitation or restlessness. Level 2 : Calm and cooperative, with orientation to time and place. Level 3 : Responds to commands, but with delayed or slurred speech. Level 4 : Sleepy, but easily arousable to voice. Level 5 : Sleepy, with a slow response to voice. Level 6 : Deeply sedated, with no response to voice or light stimulation.
Measured: 45 minutes after administration, before the induction of anesthesia
The time from the end of the surgery to the first postoperative Aldrete score ≥ 9
Measured: Day 1
The incidence of circulatory and respiratory adverse events that require medical intervention as determined by researchers from the end of surgery to the exit of PACU
Measured: From the end of surgery to the exit of PACU
Incidence of POD
Measured: Within 72 hours after the surgery was completed
Postoperative patient and anesthesiologist satisfaction score
The patients and the anesthesiologists rated the satisfaction of this anesthesia on a scale of 1 to 10. The higher the score, the higher the level of satisfaction.
Measured: Within 72 hours after the surgery was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298525
- Sponsor's protocol ID
- SPPH2025586
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Exploration and Evaluation of Dexmedetomidine Hydrochloride Nasal Spray for Pre-anesthesia Sedation in Low-Monitoring Settings
- ClinicalTrials.gov ID
- NCT07298525
- Acronym / sponsor ID
- SPPH2025586
- Keywords
- Dexmedetomidine, Sedation, Safety, Preanesthetic Medication, Monitored Anaesthesia Care, Adverse Events of Respiratory Circulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the viability of dexmedetomidine hydrochloride nasal spray under minimal or no supervision and to further investigate novel clinical applications for this medication. This study aims to investigate the following aspects: the incidence of adverse respiratory and circulatory events requiring medical intervention following the administration of dexmedetomidine nasal spray for pre-anesthetic sedation, its sedative efficacy and onset time, and its impact on the quality of post-anesthesia recovery and the occurrence of postoperative delirium. Researchers will compare dexmedetomidine hydrochloride nasal spray to a placebo (a look-alike substance that contains no drug) to see the incidence and severity of adverse events following administration. Participants will receive either dexmedetomidine nasal spray or a placebo 45 minutes before anesthesia induction. The blinded assessor will continuously monitor and record vital signs, adverse events, and the level of sedation. More importantly, observations and records should be made for respiratory and circulatory events that require medical intervention. A follow-up assessment will be conducted within three days after the operation to evaluate the incidence of postoperative delirium and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1(LD): Dexmedetomidine hydrochloride nasal spray 50μg, and placebo nasal spray 50μg | Experimental | Drug: Dexmedetomidine hydrochloride nasal spray |
| Group 2(HD): Dexmedetomidine hydrochloride nasal spray 100μg | Experimental | Drug: Dexmedetomidine hydrochloride nasal spray |
| Group 3(C): Placebo nasal spray 100μg | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be 18 years of age or older, including the age of 18; no gender limitation;
- American Society of Anesthesiologists (ASA) grade I to III;
- Require general anesthesia, intraspinal anesthesia, or nerve block anesthesia for an elective surgical procedure;
- Provide informed consent for participation in this study prior to the commencement of the trial and execute a written document of informed consent willingly.
Key exclusion criteria (11 listed)
- Individuals with a known hypersensitivity to dexmedetomidine hydrochloride or any excipient; patients with a documented allergy to any tranquilizers, opioids, or other substances employed in the trial;
- Individuals with airway hyperactivity, such as those suffering from chronic obstructive pulmonary disease (COPD), asthma, or sleep apnea, who are determined by the researchers to have experienced or are experiencing safety concerns related to these conditions;
- Patients with a history of nasal disorders, previous surgical procedures, or allergic reactions deemed clinically significant by the research team, which could significantly impact drug absorption (e.g., chronic nasal congestion, rhinorrhea, nosebleeds, and other symptoms, as well as anatomical or mucosal abnormalities in the nose that may affect drug uptake);
- A blood oxygen saturation (SpO2) level of less than or equal to 92% in a non-oxygenated state during the screening period;
- patients with current psychiatric disorders (like schizophrenia or depression) or cognitive impairment; those with a history of epilepsy; or individuals with a past record of psychotropic or narcotic substance abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine hydrochloride nasal sprayGroup 1 (LD) was administered 50 μg of dexmedetomidine hydrochloride nasal spray and 50 μg of placebo nasal spray | Drug | Group 1(LD): Dexmedetomidine hydrochloride nasal spray 50μg, and placebo nasal spray 50μg |
| PlaceboGroup 3 (C) was administered 100 μg of placebo nasal spray | Drug | Group 3(C): Placebo nasal spray 100μg |
| Dexmedetomidine hydrochloride nasal sprayGroup 2 (HD) was administered 100 μg of dexmedetomidine hydrochloride nasal spray | Drug | Group 2(HD): Dexmedetomidine hydrochloride nasal spray 100μg |
Primary outcome
Incidence of adverse events in the circulatory and respiratory system requiring medical intervention
Time frame: 45 minutes after administration, before the induction of anesthesia
5 secondary outcomes
Ramsay score
Time frame: 45 minutes after administration, before the induction of anesthesia
The time from the end of the surgery to the first postoperative Aldrete score ≥ 9
Time frame: Day 1
The incidence of circulatory and respiratory adverse events that require medical intervention as determined by researchers from the end of surgery to the exit of PACU
Time frame: From the end of surgery to the exit of PACU
Incidence of POD
Time frame: Within 72 hours after the surgery was completed
Postoperative patient and anesthesiologist satisfaction score
Time frame: Within 72 hours after the surgery was completed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine hydrochloride nasal spray in people with Dexmedetomidine and Sedation, run by Sichuan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Li (+86 13668169590, lipengmazui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events in the circulatory and respiratory system requiring medical intervention (time frame: 45 minutes after administration, before the induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.