Actively Recruiting
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
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-01-20
394
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
S
Shanghai Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Female patients aged between 20 and 70 years
- Classified as ASA I or II (American Society of Anesthesiologists physical status)
- Body mass index (BMI) between 18 and 26 kg/m²
You will not qualify if you...
- Unsuitable for nasal spray administration (e.g., severe rhinitis, nasal deformities)
- Severe bradycardia (heart rate < 50 beats/min) or history of cardiac conduction block
- History of upper respiratory tract infection
- History of asthma
- Allergy to Dexmedetomidine or local anesthetics
- Prior use of anti-anxiety medication before surgery
- History of ischemic stroke or transient ischemic attack
- Poorly controlled blood pressure despite medication
- History of mental illness, cognitive impairment, or epilepsy
- History of pregnancy
- Long-term use of sedatives or analgesics
- History of liver or kidney function impairment
- History of drug or alcohol abuse
- Any other conditions deemed disqualifying by the study reviewers
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300060
Actively Recruiting
Research Team
Y
Yajing Yuan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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