Skip to content

Efficacy and safety of ciprofol for the intraoperative sedation in lower extremity orthopedic surgery under spinal anesthesia: A Randomized Controlled Trial

Efficacy and safety of ciprofol for the intraoperative sedation in lower extremity orthopedic surgery under spinal anesthesia: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087452
Enrollment
Unknown
Registered
2024-07-26
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Lower extremity orthopedic surgery

Interventions

Sponsors

Zhongshan hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Patients scheduled for lower limb orthopedic surgery 2) 18-65y, ASA I-II 3) 18=BMI=30 kg/m2

Exclusion criteria

Exclusion criteria: 1) Patients with contraindications to deep sedation/general anesthesia or a history of sedation/anesthesia accidents 2) Known allergies to eggs, soy products, opioid drugs and their rescue drugs, propofol, etc.; contraindications to propofol, opioid drugs and their rescue drugs 3) Severe cardiovascular and cerebrovascular diseases, respiratory failure, mental disorders 4) Patients with heart failure (grade III or above), liver and kidney dysfunction 5) Patients with terminal tumors with multiple systemic metastases, or with other malignant tumors 6) Elevated preoperative body temperature, elevated white blood cell count (such as recent fever, infection) 7) Contraindications to epidural anesthesia

Design outcomes

Primary

MeasureTime frame
Sedation success rate;

Secondary

MeasureTime frame
Induce duration of sedation;Drug-related adverse reactions;

Countries

China

Contacts

Public ContactDi Zhou

Zhongshan hospital of Fudan University

zhou.di@zs-hospital.sh.cn+86 139 1704 7338

Outcome results

None listed

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