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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 394
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent for
- •The patients included in the study were women aged between 20 and
- •ASA (American Society of Anesthesiologists) I-II.
- •BMI:18-26 Kg/m ²
排除标准
- •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.
研究者
Yajing Yuan
Associate Chief Physician
Tianjin Medical University Cancer Institute and Hospital