NCT07350928

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Induction of anesthesia with dexmedetomidine nasal spray prior to surgery	Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
DRUG	Induction of anesthesia with placebo spray prior to surgery	Induction of anesthesia with placebo spray prior to surgery

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China