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

Phase 3RecruitingNCT07350928

Tianjin Medical University Cancer Institute and Hospital394 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

394

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.