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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
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.
Age
20 - 70 years
Sex
FEMALE
Healthy Volunteers
No
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Start Date
March 1, 2025
Primary Completion Date
March 1, 2026
Completion Date
March 1, 2026
Last Updated
January 20, 2026
394
ESTIMATED participants
Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
DRUG
Induction of anesthesia with placebo spray prior to surgery
DRUG
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
NCT04704661
NCT05673200
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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