Efficacy and safety of dexmedetomidine hydrochloride nasal spray for preoperative antianxiety in patients with breast cancer: a multicentre, randomized, single-blind, placebo-controlled parallel study

Phase 4

• Conditions: Preoperative anxiety

• Registration Number: ChiCTR2400089060
• Lead Sponsor: The Second Affiliated Hospital of Fujian Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients undergoing radical mastectomy under general anesthesia;<br>2) Patients aged 18-65 years;<br>3) ASA grade I-II;<br>4) Fully understand the purpose and significance of this experiment, voluntarily participate in this experiment and sign the informed consent.

Exclusion Criteria

1. Subjects who are not considered suitable for nasal spray by the researchers (such as severe rhinitis, nasal deformity, etc.);<br>2) Subjects with a history of myocardial infarction or unstable angina pectoris within 6 months prior to the screening period;<br>3) Subjects with heart rate <60 beats/min, or history of severe arrhythmias such as grade II type II or above atrioventricular block, or history of cardiac insufficiency;<br>4) Subjects with a history of ischemic stroke or transient ischemic attack (TIA);<br>5) Subjects with poor blood pressure control after medication<br>6) Subjects with psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction, or a history of epilepsy, or a history of psychotropic drugs and narcotic drug abuse;<br>7) Subjects with a history or possibility of difficult airway, such as obstructive sleep apnea syndrome;<br>8) Abnormal liver and kidney function: ALT and/or AST>2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal; Subjects with serum creatinine (Cr)>1.5 times the upper limit of normal.<br>9) Subjects with hypothyroidism<br>10) Those who are allergic to dexmedetomidine, propofol, opioids and other drug ingredients or components to be used in this test;<br>11) Pregnant or lactating women;<br>12) Those who planned to have a child between 30 days before the screening period and six months after the end of the trial, were unwilling or unable to take effective contraceptive measures;

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety scores :1 day before surgery, after dextrometin nasal spray, 12 hours after surgery and 1 day after surgery;Sleep scores: 12h and 1d after surgery;VAS scores: 12h and 1d after surgery;