Dexmedetomidine Nasal Spray for Breast-Conserving Surgery
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
Recruiting
Phase 3Interventional Study
Breast Cancer
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
394 (estimated)
Sponsor
Tianjin Medical University Cancer Institute and Hospital · Other
Who this trial is looking for
This trial is looking for women aged 20 to 70 who are having surgery for breast cancer. Participants will receive either a nasal spray medication or a placebo before the surgery and will be monitored for how they feel during and after the procedure.
Are You a Good Fit for This Trial?
Rules you outMental illnessCognitive impairmentEpilepsyPregnancyLiver function impairmentKidney function impairmentDrug abuseAlcohol abuse
You may be able to join if
I am a woman aged between 20 and 70.
I have signed the informed consent.
I have an ASA status of I or II.
My BMI is between 18 and 26.
You may not be able to join if
I have severe rhinitis or nasal deformities.
I have severe bradycardia or history of cardiac issues.
I have had an upper respiratory tract infection.
I have asthma.
I am allergic to Dexmedetomidine or local anesthetics.
I have taken anti-anxiety medication before the operation.
I have a history of ischemic stroke or transient ischemic attack.
I have poorly controlled blood pressure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 postoperati…
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.
Trial Locations
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Eligibility Criteria
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 (su…
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.
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