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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
  Induction of anesthesia with dexmedetomidine nasal spray prior to surgery
• Препарат Induction of anesthesia with placebo spray prior to surgery
  Induction of anesthesia with placebo spray prior to surgery

Первичные конечные точки

• Observer's Assessment of Alterness/Sedation and Numerical rating scale [Срок оценки: From enrollment to the end of the first postoperative day]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: From enrollment to the end of the first postoperative day]

Вторичные конечные точки (8)

• Heart rate [Срок оценки: From enrollment to the end of the first postoperative day]
• Patient and Surgeon Satisfaction Scores [Срок оценки: From enrollment to the end of the first postoperative day]
• Pain Rating (VAS Visual Analog Scale) [Срок оценки: From enrollment to the end of the first postoperative day]
• Incidence of adverse reactions [Срок оценки: From enrollment to the end of the first postoperative day]
• Restore quality assessment [Срок оценки: From enrollment to the end of the first postoperative day]
• blood pressure [Срок оценки: From enrollment to the end of the first postoperative day]
• respiratory rate [Срок оценки: From enrollment to the end of the first postoperative day]
• oxygen saturation [Срок оценки: From enrollment to the end of the first postoperative day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07350928 · E20250012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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