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

NCT07350928 | Recruiting Phase 3 DMC

• 1 other identifier: E20250012
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Heart rate

  From enrollment to the end of the first postoperative day

• Patient and Surgeon Satisfaction Scores

  From enrollment to the end of the first postoperative day

• Pain Rating (VAS Visual Analog Scale)

  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

  From enrollment to the end of the first postoperative day

Study Arms (2)

Induction of anesthesia with placebo spray prior to surgery

PLACEBO COMPARATOR

Drug: Induction of anesthesia with placebo spray prior to surgery

Induction of anesthesia with dexmedetomidine nasal spray prior to surgery

EXPERIMENTAL

Drug: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery

Interventions

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

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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yajing Yuan

CONTACT

+86 158 2294 6764; yuanyajing@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 20, 2026
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)