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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Induction of anesthesia with placebo spray prior to surgery; Drug: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery

• Study Type: Interventional
• Enrollment (Estimated): 394
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yajing Yuan; Phone Number: +86 158 2294 6764; Email: yuanyajing@tjmuch.com

Study Locations

• China
  • Tianjin, China, 300060
    • Recruiting
    • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subjects deemed unsuitable for nasal spray administration by the researchers (such as those with severe rhinitis, nasal deformities, etc.);
• Severe bradycardia (HR < 50 beats/min), history of cardiac conduction block;
• History of upper respiratory tract infection;
• History of asthma;
• History of allergy to DEX or local anesthetics;
• Subjects who have taken anti-anxiety medication before the operation;
• Subjects with a history of ischemic stroke or transient ischemic attack;
• Subjects with poorly controlled blood pressure despite medication;
• Subjects with a history of mental illness, cognitive impairment, or epilepsy;
• Subjects with a history of pregnancy;
• Subjects who have been taking sedatives or analgesics for a long time;
• Subjects with a history of liver or kidney function impairment;
• Subjects with a history of drug or alcohol abuse;
• Other situations that the reviewers consider to be disqualifying based on the registration study, such as potential non-compliance with the clinical protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Induction of anesthesia with placebo spray prior to surgery	Drug: Induction of anesthesia with placebo spray prior to surgery; Induction of anesthesia with placebo spray prior to surgery
Experimental: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery	Drug: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery; Induction of anesthesia with dexmedetomidine nasal spray prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observer's Assessment of Alterness/Sedation and Numerical rating scale	Used to assess the depth of patient sedation or anesthesia. This scale is primarily applied during surgery, intensive care, or sedation therapy. By observing indicators such as behavioral responses, facial expressions, and limb movements, it categorizes sedation levels into five grades (1-5 points). This aids healthcare providers in real-time monitoring and adjustment of sedation protocols to ensure safety and efficacy. By evaluating sedation scores, the sedative effect of dexmedetomidine hydrochloride can be quantified to determine whether it provides adequate sedation during surgery, ensuring patient comfort and cooperation.	From enrollment to the end of the first postoperative day
Hospital Anxiety and Depression Scale (HADS)	The HADS is a commonly used tool for assessing patients' anxiety and depression, particularly in hospital settings. This scale consists of seven anxiety items and seven depression items, designed for rapid screening of anxiety and depression symptoms in patients. Scale Structure: Anxiety Section (HADS-A): 7 items, assessing patients' anxiety. Depression Section (HADS-D): 7 items, assessing patients' depression. Scoring Method: Each item is scored 0-3 points, yielding a total score range of 0-21 points. Higher scores indicate greater severity of anxiety or depression. 0-7 points: Normal 8-10 points: Mild 11-14 points: Moderate 15 points and above: Severe HADS can screen patients' anxiety and depression status prior to medication administration, assisting healthcare providers in developing appropriate psychological intervention measures.	From enrollment to the end of the first postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate		From enrollment to the end of the first postoperative day
Patient and Surgeon Satisfaction Scores	Measurement Method: Patients and surgeons are each asked to rate the effectiveness of anesthesia and intraoperative sedation.	From enrollment to the end of the first postoperative day
Pain Rating (VAS Visual Analog Scale)	Use the Visual Analogue Scale (VAS) to assess pain intensity at different postoperative time points. Visual Analogue Scale (VAS) 0 points: No pain 1-3 points: Mild pain 4-6 points: Moderate pain 7-10 points: Severe pain	From enrollment to the end of the first postoperative day
Incidence of adverse reactions		From enrollment to the end of the first postoperative day
Restore quality assessment	Using the Quality of Recovery (QOR) Questionnaire Content: Assesses aspects including fatigue, pain, emotional state, and functional recovery. The scale ranges from 0 to 100 points, with higher scores indicating better recovery quality.	From enrollment to the end of the first postoperative day
blood pressure		From enrollment to the end of the first postoperative day
respiratory rate		From enrollment to the end of the first postoperative day
oxygen saturation		From enrollment to the end of the first postoperative day

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: E20250012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No