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Effect of dexmedetomidine hydrochloride nasal spray on postoperative sleep quality in patients undergoing breast cancer surgery: a randomized controlled study

Effect of dexmedetomidine hydrochloride nasal spray on postoperative sleep quality in patients undergoing breast cancer surgery: a randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109368
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-09-22

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

Conditions

Breast cancer

Interventions

Dexmedetomidine nasal spray (Group D):At 30min before anesthesia induction, dexmedetomidine was sprayed into the nasal cavity, 1 spout was sprayed into each nostrils, and then 1 spout was sprayed into
Blank control group (Group C):Placebo saline was sprayed into the nasal cavity at 30min before induction of anesthesia, and 1 spout was sprayed into each nostril for 30s, then 1 spout was sprayed into

Sponsors

Department of Anesthesiology, The Central Hospital of Wuhan
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~75 years old; 2. Female; 3. Breast cancer surgery, anesthesia time <=4 h; 4. American Society of Anesthesiologists (ASA) grade I.~III; 5. Body mass index (BMI) 18-30 kg/m²; 6. Able to voluntarily cooperate with this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women and women with a birth plan within 3 months; 2. Patients with severe cardiac, lung, liver, and kidney dysfunction; 3. Patients with severe neuropsychiatric disorders or cognitive dysfunction; 4. Sinus bradycardia ( 7 points.

Design outcomes

Primary

MeasureTime frame
PSQI score on the night after the surgery;

Secondary

MeasureTime frame
PSQI score on the 2nd and 3rd night after surgery;APAIS scores before and after medication administration;Time of extubation;Time to full consciousness;Duration of stay in the PACU;Usage of vasoactive drugs during anesthesia;Incidence of adverse events during anesthesia and recovery process;Patient and anesthesiologist satisfaction ratings;Postoperative VAS score on days 1-3;RASS scores before and after medication administration;

Countries

China

Contacts

Public ContactYingge Liu

Department of Anesthesiology, The Central Hospital of Wuhan

2238478300@qq.com+86 134 7731 0272

Outcome results

None listed

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