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Recruiting 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

Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Induction of anesthesia with dexmedetomidine nasal spray prior to surgery, Induction of anesthesia with placebo spray prior to surgery.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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.

Interventions

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

Primary outcome measures

  • Observer's Assessment of Alterness/Sedation and Numerical rating scale [Time frame: From enrollment to the end of the first postoperative day]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: From enrollment to the end of the first postoperative day]
Secondary outcome measures (8)
  • Heart rate [Time frame: From enrollment to the end of the first postoperative day]
  • Patient and Surgeon Satisfaction Scores [Time frame: From enrollment to the end of the first postoperative day]
  • Pain Rating (VAS Visual Analog Scale) [Time frame: From enrollment to the end of the first postoperative day]
  • Incidence of adverse reactions [Time frame: From enrollment to the end of the first postoperative day]
  • Restore quality assessment [Time frame: From enrollment to the end of the first postoperative day]
  • blood pressure [Time frame: From enrollment to the end of the first postoperative day]
  • respiratory rate [Time frame: From enrollment to the end of the first postoperative day]
  • oxygen saturation [Time frame: From enrollment to the end of the first postoperative day]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07350928 · E20250012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗