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A Study on the Safety and Efficacy of Intranasal Dexmedetomidine Hydrochloride for Segmental Mastectomy Under Local Anesthesia

A Study on the Safety and Efficacy of Intranasal Dexmedetomidine Hydrochloride for Segmental Mastectomy Under Local Anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116271
Enrollment
Unknown
Registered
2026-01-07
Start date
2026-01-09
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Perioperative anxiety and postoperative pain in patients with benign breast masses.

Interventions

Dexmedetomidine Group:Patients in this group will receive nasal spray of dexmedetomidine.
Control Group:Patients in this group will receive nasal spray of saline solution.

Sponsors

Cancer Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients scheduled to undergo unilateral breast lesion excision under sedation with anesthetic monitoring; 2.aged between 18 and 70 years; 3.classified as ASA I-II; 4.with New York Heart Association (NYHA) functional class I-II; 5.and a body mass index (BMI) < 30 kg/m^².

Exclusion criteria

Exclusion criteria: 1.Patients who are deemed unsuitable for intranasal administration by the investigator, such as those with severe rhinitis, nasal polyps, or nasal deformities. 2.Patients with severe heart failure, arrhythmias, sinus bradycardia, obstructive sleep apnea syndrome, or other respiratory diseases; liver or kidney dysfunction; severe hypertension, diabetes, obesity, or other serious comorbidities. 3.Patients with a history of breast cancer surgery. 4.Patients with a history of local anesthetic allergy. 5.Patients with active systemic infections or those who have recently undergone corticosteroid or steroid therapy. 6.Patients with chronic pain or anxiety lasting more than 3 months, a history of long-term use of analgesics or sedatives, or a history of substance abuse. 7.Patients with preoperative cognitive impairment or hearing loss that prevents cooperation during the study.

Design outcomes

Primary

MeasureTime frame
Intraoperative Opioid Consumption;

Secondary

MeasureTime frame
Sleep quality;Postoperative pain;Perioperative anxiety;

Countries

China

Contacts

Public ContactYan Tao

Cancer Hospital Chinese Academy of Medical Sciences

blizzardyt@163.com+86 10 8778 7024

Outcome results

None listed

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