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NCT Number: NCT07350928

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

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 placebo spray prior to surgery

Drug

Induction of anesthesia with placebo spray prior to surgery

Primary outcomes

  1. Observer's Assessment of Alterness/Sedation and Numerical rating scale

    Time frame: From enrollment to the end of the first postoperative day

    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.

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: From enrollment to the end of the first postoperative day

    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.

Secondary outcomes

  1. Heart rate

    Time frame: From enrollment to the end of the first postoperative day

  2. Patient and Surgeon Satisfaction Scores

    Time frame: From enrollment to the end of the first postoperative day

    Measurement Method: Patients and surgeons are each asked to rate the effectiveness of anesthesia and intraoperative sedation.

  3. Pain Rating (VAS Visual Analog Scale)

    Time frame: From enrollment to the end of the first postoperative day

    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

  4. Incidence of adverse reactions

    Time frame: From enrollment to the end of the first postoperative day

  5. Restore quality assessment

    Time frame: From enrollment to the end of the first postoperative day

    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.

  6. blood pressure

    Time frame: From enrollment to the end of the first postoperative day

  7. respiratory rate

    Time frame: From enrollment to the end of the first postoperative day

  8. oxygen saturation

    Time frame: From enrollment to the end of the first postoperative day

Study contacts

Contact information is provided by the study sponsor or research team.

Yajing Yuan

CONTACT

[email protected]

+86 158 2294 6764

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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