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A prospective randomized controlled Trial on the Correlation between Sufentanil Dose Selection and Electroencephalogram Dynamic Changes and Postoperative Sleep Quality in Patients undergoing breast Cancer surgery

A prospective randomized controlled Trial on the Correlation between Sufentanil Dose Selection and Electroencephalogram Dynamic Changes and Postoperative Sleep Quality in Patients undergoing breast Cancer surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125697
Enrollment
Unknown
Registered
2026-05-29
Start date
2025-09-24
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Postoperative sleep in patients undergoing breast cancer surgery

Interventions

High-dose Sufentanil group (Group 1: Multi-opioid group):Sufentanil 0.5µg/kg induction, additional 0.1µg/kg administered 5min before incision and 5min before axillary dissection
no regional block
Low-dose Sufentanil group (Group 2: Minimal-opioid group):Sufentanil 0.3µg/kg induction, no intraoperative supplementation

Sponsors

The Second Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18-65 years old; 2. Diagnosed with breast cancer; 3. Scheduled for unilateral modified radical mastectomy or breast conserving surgery (expected surgery > 1.5 h); 4. ASA grade I-II; 5. BMI 18-30 kg/m²; 6. Preoperative PSQI = 7 (no clinical sleep disorder); 7. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Opioid abuse or allergy within 6 months before operation; 2. SAPB taboo (puncture site infection, coagulation abnormality, local anesthetic allergy); 3. Preoperative neuropsychiatric disease (e.g., depression, epilepsy) or sleep disorder (AHI = 15); 4. Severe heart, liver, and kidney dysfunction (Child-Pugh B grade or higher); 5. Cognitive impairment; 6. Intraoperative conversion to thoracotomy or postoperative admission to ICU; 7. Poor follow-up compliance.

Design outcomes

Primary

MeasureTime frame
Total sleep time TST;The proportion of deep sleep N3;REM ratio of rapid eye movement sleep;Awakening times NW;Pittsburgh Sleep Quality Index ( PSQI );Athens Insomnia Scale ( AIS );The percentage of d ( 0.5 ~ 4Hz ) wave in frontal lobe, temporal lobe, central area and occipital lobe.;The percentage of ? ( 4 ~ 8Hz ) wave in frontal lobe, temporal lobe, central area and occipital lobe.;The percentage of a ( 8 ~ 13Hz ) wave in frontal lobe, temporal lobe, central area and occipital lobe.;The percentage of ß ( 13 ~ 30Hz ) wave in frontal lobe, temporal lobe, central area and occipital lobe.;—

Countries

China

Contacts

Public ContactLi Yu

The Second Affiliated Hospital of Guangxi Medical University

24769934@qq.com+86 159 7749 6449

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026