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Construction and Verification of Risk Prediction Model for Sleep Disturbance After Radical Mastectomy: A Prospective Cohort Study

Construction and Verification of Risk Prediction Model for Sleep Disturbance After Radical Mastectomy: A Prospective Cohort Study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060607
Enrollment
Unknown
Registered
2022-06-05
Start date
2022-05-23
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Sleep disturbance

Interventions

sevo+dex:Sevoflurane anesthesia+dexmedetomidine
propofol+dex:Propofol anesthesia+dexmedetomidine
sevo+esk:Sevoflurane anesthesia+esketamine
propofol+esk:Propofol anesthesia+esketamine
sevo:Sevoflurane anesthesia
propofol:Propofol anesthesia

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 35-65 years old; 2. ASA grade I - III; 3. BMI 18.5 -35kg/m2; 4. Cases were diagnosed as breast cancer; 5. Elective radical mastectomy for breast cancer (modified); 6. Informed consent to surgery and this study.

Exclusion criteria

Exclusion criteria: Those who have one of the following circumstances will not be selected as cases: refuse to participate in this study; Preoperative diagnosis was dementia, Alzheimer's disease, delirium and brain metastasis; Unable to communicate or cooperate with relevant examinations due to language disorders or end-stage diseases; Previous diagnosis of central sleep apnea; Have a history of drug or alcohol dependence or have taken sedative / hypnotic drugs within 1 month; History of schizophrenia or mental illness within 3 months or current use of antipsychotics (including antidepressants and anxiolytics); Sick sinus syndrome, severe bradycardia (heart rate < 50 beats/ min), or atrioventricular block of grade II and above without pacemaker; Allergic to DEX or ESK; Patients with elevated intracranial pressure; Poorly controlled or untreated patients with hypertension (arterial hypertension, resting systolic / diastolic blood pressure exceeding 180 / 100mmhg); Patients with hyperthyroidism (hyperthyroidism) without treatment or insufficient treatment; It is expected that endotracheal intubation will be required to enter the ICU after operation; Other researchers think it is not suitable to be selected (specific reasons shall be indicated).

Design outcomes

Primary

MeasureTime frame
PSG outcomes;

Secondary

MeasureTime frame
RCQS score;Richmond Agitation-Sedation Scale;Subjective sleep score;Actigraph outcomes;VAS scores;nausea and vomiting;Perioperative outcomes;PSQI;

Countries

China

Contacts

Public ContactTan Hongyu
maggitan@163.com+86 18610265968

Outcome results

None listed

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