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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yajing Yuan
• Email: yuanyajing@tjmuch.com
• Phone: +86 158 2294 6764

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.