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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089060
Enrollment
Unknown
Registered
2024-08-30
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative anxiety

Interventions

Group C:using normal saline nasal spray
Group D1:using Dextrome nasal spray 50ug
Group D2:using Dextrome nasal spray 75ug
Group D3:using Dextrome nasal spray 100ug

Sponsors

The Second Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1) Subjects who are not considered suitable for nasal spray by the researchers (such as severe rhinitis, nasal deformity, etc.); 2) Subjects with a history of myocardial infarction or unstable angina pectoris within 6 months prior to the screening period; 3) Subjects with heart rate 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. 9) Subjects with hypothyroidism 10) Those who are allergic to dexmedetomidine, propofol, opioids and other drug ingredients or components to be used in this test; 11) Pregnant or lactating women; 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;

Design outcomes

Primary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactHe Hefan

The Second Affiliated Hospital of Fujian Medical University

15860905262@163.com+86 158 6090 5262

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026