Safety and Efficacy of Ciprofol versus Propofol in Breast Biopsy under Local Anesthesia

Comparison of the Safety and Efficacy of Ciprofol and Propofol in Breast Biopsy under Local Anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500112358

Enrollment

Unknown

Registered

2025-11-13

Start date

2025-11-17

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Breast nodule / suspected breast cancer lesion (requiring biopsy for diagnosis)

Interventions

Propofol group:Propofol combined with Sufentanil

Ciprofol group:Ciprofol combined with Sufentanil

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–65 years; 2.ASA physical status I–II; 3.BMI 18–30 kg/m^2; 4.Mallampati airway classification I–II,; 5.no abnormality in airway assessment; 6.Scheduled for breast biopsy under local anesthesia; 7.Signed informed consent;

Exclusion criteria

Exclusion criteria: 1.History of adverse reactions to sedation or general anesthesia; 2.Allergy to opioids, propofol, ciprofol; 3.their components Current use of drugs with synergistic effects with propofol or ciprofol; 4.Severe cardiovascular or respiratory disease; 5.Hepatic or renal insufficiency (ALT/AST >1.5 × ULN or creatinine clearance <60 ml/min); 6.Psychiatric disorders or cognitive impairment preventing cooperation;

Design outcomes

Primary

Measure	Time frame
Sedation success rate;	—

Secondary

Measure	Time frame
Incidence of adverse events;Recovery time;Onset time of sedation;Vital signs and hemodynamic parameters;	—

Countries

China

Contacts

Public ContactLu Yan

Affiliated Hospital of Guangdong Medical University

stormbird2004@21cn.com+86 759 236 9336

Outcome results

None listed

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