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Effect of intraoperative intravenous infusion of eskelamine combined with dexmedetomidine on postoperative sleep disturbance in patients undergoing modified radical mastectomy

Effect of intraoperative intravenous infusion of eskelamine combined with dexmedetomidine on postoperative sleep disturbance in patients undergoing modified radical mastectomy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086026
Enrollment
Unknown
Registered
2024-06-24
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

breast cancer

Interventions

Esketamine group:Esketamine 0.3mg/kg/h was pumped continuously during the operation
Dexmedetomidine group:During the operation, dextrometin was injected continuously with 0.4ug /kg/h
Esketamine combined with dexmedetomidine group:Intraoperatively, dextromete 0.4ug /kg/h and esketamine 0.3mg/kg/h were continuously pumped

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Women undergoing modified radical surgery for breast cancer under elective general anesthesia; 2. Age 18-65 years old; 3.ASA grade I - III; 4.BMI 18-30 kg/m^2; 5. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Preoperative sleep disorder, AIS > 6 or PSQI=10; 2. Long-term use of sedative hypnotic drugs to help sleep before surgery; 3. Patients with communication and understanding disorders (language disorders, mental disorders) who cannot complete the scale test; 4. Preoperative sick sinus syndrome, severe sinus bradycardia (HR < 50 beats/min), atrioventricular block II or above and no pacemaker; 5. Obstructive sleep apnea syndrome, STOP-Bang score =3 points; 6. Severe liver and kidney dysfunction; 7. Patients with serious risk of elevated blood pressure or intracranial pressure; 8. Patients with untreated or undertreated hyperthyroidism; 9. People who are allergic to the drugs involved in this experiment

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disorders in the first three nights after surgery;

Secondary

MeasureTime frame
Postoperative sleep structure;Anxiety and depression score;postoperation pain;Postoperative recovery quality;Postoperative adverse events;

Countries

China

Contacts

Public ContactChen Xiuxia

The Affiliated Hospital of Xuzhou Medical University

cxxlxy@sina.com+86 180 5226 8332

Outcome results

None listed

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