Breast CancerPhase 3NCT07350928
Observation of the Effect of Preoperative Use of Dexmedetomidine Hydrochloride Nasal Spray on Optimizing Awake Sedation During Breast-Conserving Surgery for Breast Cancer and Postoperative Awake Status
A Phase 3 study testing Induction of anesthesia with dexmedetomidine nasal spray prior to surgery in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy and safety of Dexmedetomidine Hydrochloride Nasal Spray for conscious sedation and anxiety relief during breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Phase 3
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent for
- The patients included in the study were women aged between 20 and 70.
- ASA (American Society of Anesthesiologists) I-II.
- BMI:18-26 Kg/m ²
Who cannot join
- Subjects deemed unsuitable for nasal spray administration by the researchers (such as those with severe rhinitis, nasal deformities, etc.);
- Severe bradycardia (HR < 50 beats/min), history of cardiac conduction block;
- History of upper respiratory tract infection;
- History of asthma;
- History of allergy to DEX or local anesthetics;
- Subjects who have taken anti-anxiety medication before the operation;
Show all 14Show fewer
- Subjects with a history of ischemic stroke or transient ischemic attack;
- Subjects with poorly controlled blood pressure despite medication;
- Subjects with a history of mental illness, cognitive impairment, or epilepsy;
- Subjects with a history of pregnancy;
- Subjects who have been taking sedatives or analgesics for a long time;
- Subjects with a history of liver or kidney function impairment;
- Subjects with a history of drug or alcohol abuse;
- Other situations that the reviewers consider to be disqualifying based on the registration study, such as potential non-compliance with the clinical protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060
About this study
Official title: A Phase III Randomized Controlled Clinical Trial Evaluating the Efficacy of Preoperative Dexmedetomidine Hydrochloride Nasal Spray in Optimizing Awake Sedation During Breast-Conserving Surgery for Breast Cancer and Postoperative Awake Status
This clinical trial aims to evaluate the efficacy and safety of Dexmedetomidine Hydrochloride Nasal Spray for conscious sedation and anxiety relief during breast-conserving surgery. The main questions it aims to answer are:
Does Dexmedetomidine Hydrochloride Nasal Spray effectively provide intraoperative sedation and improve postoperative awakening time? What changes in vital signs or postoperative complications do participants experience when using this medication?
Read more
Researchers will compare Dexmedetomidine Hydrochloride Nasal Spray to a placebo (saline nasal spray) to determine its efficacy in breast-conserving surgery.
Participants will:
Receive preoperative administration of either Dexmedetomidine Hydrochloride Nasal Spray or the placebo nasal spray; Undergo regular intraoperative and postoperative assessments, including sedation scores, awakening time, and pain scores; Provide satisfaction feedback and be monitored for changes in vital signs and complications.
- Conditions
- Breast Cancer
- Being tested
- Induction of anesthesia with dexmedetomidine nasal spray prior to surgery, Induction of anesthesia with placebo spray prior to surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of anesthesia with dexmedetomidine nasal spray prior to surgeryDrug
Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
Induction of anesthesia with placebo spray prior to surgeryDrug
Induction of anesthesia with placebo spray prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Induction of anesthesia with placebo spray prior to surgery | Placebo comparator | Not described Receives: Drug: Induction of anesthesia with placebo spray prior to surgery |
| Induction of anesthesia with dexmedetomidine nasal spray prior to surgery | Experimental | Not described Receives: Drug: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observer's Assessment of Alterness/Sedation and Numerical rating scale
Used to assess the depth of patient sedation or anesthesia. This scale is primarily applied during surgery, intensive care, or sedation therapy. By observing indicators such as behavioral responses, facial expressions, and limb movements, it categorizes sedation levels into five grades (1-5 points). This aids healthcare providers in real-time monitoring and adjustment of sedation protocols to ensure safety and efficacy. By evaluating sedation scores, the sedative effect of dexmedetomidine hydrochloride can be quantified to determine whether it provides adequate sedation during surgery, ensuring patient comfort and cooperation.
Measured: From enrollment to the end of the first postoperative day
Hospital Anxiety and Depression Scale (HADS)
The HADS is a commonly used tool for assessing patients' anxiety and depression, particularly in hospital settings. This scale consists of seven anxiety items and seven depression items, designed for rapid screening of anxiety and depression symptoms in patients.
Scale Structure:
Anxiety Section (HADS-A): 7 items, assessing patients' anxiety. Depression Section (HADS-D): 7 items, assessing patients' depression.
Scoring Method:
Each item is scored 0-3 points, yielding a total score range of 0-21 points. Higher scores indicate greater severity of anxiety or depression.
0-7 points: Normal 8-10 points: Mild 11-14 points: Moderate 15 points and above: Severe HADS can screen patients' anxiety and depression status prior to medication administration, assisting healthcare providers in developing appropriate psychological intervention measures.
Measured: From enrollment to the end of the first postoperative day
Secondary outcomes (8)
Heart rate
Measured: From enrollment to the end of the first postoperative day
Patient and Surgeon Satisfaction Scores
Measurement Method: Patients and surgeons are each asked to rate the effectiveness of anesthesia and intraoperative sedation.
Measured: From enrollment to the end of the first postoperative day
Pain Rating (VAS Visual Analog Scale)
Use the Visual Analogue Scale (VAS) to assess pain intensity at different postoperative time points.
Visual Analogue Scale (VAS) 0 points: No pain 1-3 points: Mild pain 4-6 points: Moderate pain 7-10 points: Severe pain
Measured: From enrollment to the end of the first postoperative day
Incidence of adverse reactions
Measured: From enrollment to the end of the first postoperative day
Restore quality assessment
Using the Quality of Recovery (QOR) Questionnaire Content: Assesses aspects including fatigue, pain, emotional state, and functional recovery. The scale ranges from 0 to 100 points, with higher scores indicating better recovery quality.
Measured: From enrollment to the end of the first postoperative day
blood pressure
Measured: From enrollment to the end of the first postoperative day
respiratory rate
Measured: From enrollment to the end of the first postoperative day
oxygen saturation
Measured: From enrollment to the end of the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yajing Yuan, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350928
- Sponsor's protocol ID
- E20250012
- Status last verified
- Mar 2025
- First submitted
- 15 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Controlled Clinical Trial Evaluating the Efficacy of Preoperative Dexmedetomidine Hydrochloride Nasal Spray in Optimizing Awake Sedation During Breast-Conserving Surgery for Breast Cancer and Postoperative Awake Status
- ClinicalTrials.gov ID
- NCT07350928
- Acronym / sponsor ID
- E20250012
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
This clinical trial aims to evaluate the efficacy and safety of Dexmedetomidine Hydrochloride Nasal Spray for conscious sedation and anxiety relief during breast-conserving surgery. The main questions it aims to answer are:
Does Dexmedetomidine Hydrochloride Nasal Spray effectively provide intraoperative sedation and improve postoperative awakening time? What changes in vital signs or postoperative complications do participants experience when using this medication?
Researchers will compare Dexmedetomidine Hydrochloride Nasal Spray to a placebo (saline nasal spray) to determine its efficacy in breast-conserving surgery.
Participants will:
Receive preoperative administration of either Dexmedetomidine Hydrochloride Nasal Spray or the placebo nasal spray; Undergo regular intraoperative and postoperative assessments, including sedation scores, awakening time, and pain scores; Provide satisfaction feedback and be monitored for changes in vital signs and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction of anesthesia with placebo spray prior to surgery | Placebo comparator | Drug: Induction of anesthesia with placebo spray prior to surgery |
| Induction of anesthesia with dexmedetomidine nasal spray prior to surgery | Experimental | Drug: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign the informed consent for
- The patients included in the study were women aged between 20 and 70.
- ASA (American Society of Anesthesiologists) I-II.
- BMI:18-26 Kg/m ²
Key exclusion criteria (14 listed)
- Subjects deemed unsuitable for nasal spray administration by the researchers (such as those with severe rhinitis, nasal deformities, etc.);
- Severe bradycardia (HR < 50 beats/min), history of cardiac conduction block;
- History of upper respiratory tract infection;
- History of asthma;
- History of allergy to DEX or local anesthetics;
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 |
|---|---|---|
| Induction of anesthesia with dexmedetomidine nasal spray prior to surgeryInduction of anesthesia with dexmedetomidine nasal spray prior to surgery | Drug | Induction of anesthesia with dexmedetomidine nasal spray prior to surgery |
| Induction of anesthesia with placebo spray prior to surgeryInduction of anesthesia with placebo spray prior to surgery | Drug | Induction of anesthesia with placebo spray prior to surgery |
Primary outcome
Observer's Assessment of Alterness/Sedation and Numerical rating scale
Time frame: From enrollment to the end of the first postoperative day
Used to assess the depth of patient sedation or anesthesia. This scale is primarily applied during surgery, intensive care, or sedation therapy. By observing indicators such as behavioral responses, facial expressions, and limb movements, it categorizes sedation levels into five grades (1-5 points). This aids healthcare providers in real-time monitoring and adjustment of sedation protocols to ensure safety and efficacy. By evaluating sedation scores, the sedative effect of dexmedetomidine hydrochloride can be quantified to determine whether it provides adequate sedation during surgery, ensuring patient comfort and cooperation.
Hospital Anxiety and Depression Scale (HADS)
Time frame: From enrollment to the end of the first postoperative day
The HADS is a commonly used tool for assessing patients' anxiety and depression, particularly in hospital settings. This scale consists of seven anxiety items and seven depression items, designed for rapid screening of anxiety and depression symptoms in patients. Scale Structure: Anxiety Section (HADS-A): 7 items, assessing patients' anxiety. Depression Section (HADS-D): 7 items, assessing patients' depression. Scoring Method: Each item is scored 0-3 points, yielding a total score range of 0-21 points. Higher scores indicate greater severity of anxiety or depression. 0-7 points: Normal 8-10 points: Mild 11-14 points: Moderate 15 points and above: Severe HADS can screen patients' anxiety and depression status prior to medication administration, assisting healthcare providers in developing appropriate psychological intervention measures.
8 secondary outcomes
Heart rate
Time frame: From enrollment to the end of the first postoperative day
Patient and Surgeon Satisfaction Scores
Time frame: From enrollment to the end of the first postoperative day
Pain Rating (VAS Visual Analog Scale)
Time frame: From enrollment to the end of the first postoperative day
Incidence of adverse reactions
Time frame: From enrollment to the end of the first postoperative day
Restore quality assessment
Time frame: From enrollment to the end of the first postoperative day
blood pressure
Time frame: From enrollment to the end of the first postoperative day
respiratory rate
Time frame: From enrollment to the end of the first postoperative day
oxygen saturation
Time frame: From enrollment to the end of the first postoperative day
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 20 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Induction of anesthesia with dexmedetomidine nasal spray prior to surgery in people with Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 14 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yajing Yuan (+86 158 2294 6764, yuanyajing@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observer's Assessment of Alterness/Sedation and Numerical rating scale (time frame: From enrollment to the end of the first postoperative day). The study lists 2 primary outcomes in all. 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 20 Jan 2026.