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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
Sponsor: Tianjin Medical University Cancer Institute and Hospital
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
394
Start Date
2025-03-01
Completion Date
2026-03-01
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
Induction of anesthesia with placebo spray prior to surgery
Induction of anesthesia with placebo spray prior to surgery
Locations (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China