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Effect of esketamine on intraoperative EEG and postoperative sleep quality in breast cancer patients under general anesthesia

Effect of esketamine on intraoperative EEG and postoperative sleep quality in breast cancer patients under general anesthesia

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092257
Enrollment
Unknown
Registered
2024-11-13
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Postoperative sleep disorders

Interventions

Experimental group:Anesthesia induction options: patients with propofol 1.5 mg-kg-1, sufentanil 0.5 µg-kg-1, and esketamine 0.4 mg-kg-1. Sedation and analgesia were maintained with propofol 2-10 mg/kg
Control subjects:Anesthesia induction was selected by propofol 1.5 mg-kg-1 + sufentanil 0.5 µg-kg-1 using propofol 5-10 mg-kg-1-h-1 and remifentanil 5-10 µg.kg-1.h-1 pumping for maintenance of sedatio

Sponsors

Liaoning Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. No contraindications to anesthesia, no serious underlying diseases before surgery, no heart, liver and kidney dysfunction, etc. 2. Female patients who intend to undergo breast cancer surgery, including total mastectomy, partial mastectomy, breast-conserving surgery, and breast reconstruction surgery. 3. Age 18-55 years old, ASAI.~II 4. Preoperative SDS score < 50, SAS score < 50 5. No history of mental illness (such as depression, anxiety, schizophrenia, etc.) or neurological disease (such as epilepsy, Parkinson's disease, etc.), and currently not receiving any medication that may affect the function of the central nervous system. 6. No history of long-term use of psychoactive drugs (such as antidepressants, antipsychotics, benzodiazepines, etc.) or narcotic drug addiction. 7. No history of chronic sleep disorders, such as insomnia, sleep apnea syndrome, etc., and have not received any form of sleep therapy in the last month. 8. No serious cardiovascular, respiratory, liver and kidney dysfunction, such as heart failure, severe chronic obstructive pulmonary disease, end-stage renal disease, etc. 9. No recent (past 6 months) history of major surgical surgery or trauma. 10. Patients with early-stage or intermediate-stage breast cancer without distant metastasis. 11. Patient voluntarily signed informed consent, indicating that he understands the study content, possible risks and benefits, and is willing to participate in the entire study process.

Exclusion criteria

Exclusion criteria: 1. Any patient with contraindications to surgery or anesthesia. 2. Patients at risk for the use of esketamine (including hypertension and other cardiovascular diseases, glaucoma, pregnant or lactating women) 3. Patients with hyperthyroidism (hyperthyroidism). 4. Patients who are unwilling or unable to cooperate in completing the requirements of the study before or after surgery. 5. Patients who have received radiotherapy or chemotherapy that may affect the effect of anesthesia or study intervention.

Design outcomes

Primary

MeasureTime frame
Postoperative sleep quality;

Countries

China

Contacts

Public ContactHuang Zeqing

Liaoning Cancer Hospital & Institute

huangzeqing1973@163.com+86 189 0091 7545

Outcome results

None listed

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