Observation of the Effect of Preoperative Use of Dexmedetomidine Hydrochloride Nasal Spray on Opt… (NCT07350928) | Clinical Trial Compass
RecruitingPhase 3
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
China394 participantsStarted 2025-03-01
Plain-language 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. 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.
Who can participate
Age range
20 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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;
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Observer's Assessment of Alterness/Sedation and Numerical rating scale
Timeframe: From enrollment to the end of the first postoperative day
2
Hospital Anxiety and Depression Scale (HADS)
Timeframe: From enrollment to the end of the first postoperative day
Trial details
NCT IDNCT07350928
SponsorTianjin Medical University Cancer Institute and Hospital