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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 394
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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.
Investigators
Yajing Yuan
Associate Chief Physician
Tianjin Medical University Cancer Institute and Hospital