Clinical Trial: 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
Status:
RECRUITINGPhase:
Phase 3| Lead Sponsor: | Tianjin Medical University Cancer Institute and Hospital |
| Information Provided By: | Tianjin Medical University Cancer Institute and Hospital |
| Last Update Posted: | 2026-01-20 |
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
- Drug: Induction of anesthesia with placebo spray prior to surgery
Other Study ID Numbers
- E20250012
Start Date (Actual)
Primary Completion Date (Estimated)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Tianjin Medical University Cancer Institute and Hospital |
| Information Provided By: | Tianjin Medical University Cancer Institute and Hospital |
| Last Update Posted: | 2026-01-20 |
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.
Official Title
Conditions
Intervention / Treatment
- Drug: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
- Drug: Induction of anesthesia with placebo spray prior to surgery
Other Study ID Numbers
- E20250012