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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• Sign the informed consent for

• The patients included in the study were women aged between 20 and 70.

• ASA (American Society of Anesthesiologists) I-II.

• BMI:18-26 Kg/m ²

Locations
Other Locations
China
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Contact Information
Primary
Yajing Yuan
yuanyajing@tjmuch.com
+86 158 2294 6764
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 394
Treatments
Placebo_comparator: Induction of anesthesia with placebo spray prior to surgery
Experimental: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Hengrui Pharmaceutical Co., Ltd.
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov

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