Dexmedetomidine nasal spray to improve awake sedation for breast-conserving surgery

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 will try a dexmedetomidine nasal spray before breast-conserving surgery in women with breast cancer to provide calm sedation during the operation and help them wake up smoothly afterwards.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 394 (estimated)
• Ages: 20 Years to 70 Years
• Sex: Female
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Locations: 1 site (Tianjin)
• Trial ID: NCT07350928 on ClinicalTrials.gov

What this trial studies

This Phase 3, interventional, placebo-controlled study gives women scheduled for breast-conserving surgery a preoperative dose of dexmedetomidine hydrochloride nasal spray or a saline placebo. Participants will undergo regular intraoperative and postoperative monitoring including sedation scores, vital signs, awakening time, pain scores, and recording of any complications. Patients will also provide satisfaction feedback and be followed for safety outcomes. The trial is conducted at Tianjin Medical University Cancer Institute and Hospital.

Who should consider this trial

Good fit: Women aged 20–70 with breast cancer who are scheduled for breast-conserving surgery, classified as ASA I–II and with BMI 18–26 kg/m2 and no contraindications to intranasal dexmedetomidine are ideal candidates.

Not a fit: Patients with severe nasal disease, significant bradycardia or conduction block, asthma, allergy to dexmedetomidine, pregnancy, long-term sedative use, or other listed exclusion criteria are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the nasal spray could reduce intraoperative anxiety and provide smoother, faster postoperative awakening and recovery.

How similar studies have performed: Previous studies of intranasal dexmedetomidine have shown benefit for procedural sedation and anxiolysis in other clinical settings, but its specific use for awake sedation in breast-conserving surgery is less well established.

Eligibility criteria

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.

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Yajing Yuan

Conditions Breast Cancer