Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07350928
PHASE3

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

View on ClinicalTrials.gov

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

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

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China