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Blood protective effect and organ perfusion safety of controlled hypotension in high-altitude orthopedic surgery: a prospective randomized controlled clinical study

Blood protective effect and organ perfusion safety of controlled hypotension in high-altitude orthopedic surgery: a prospective randomized controlled clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108456
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Femoral fracture, humeral fracture, Spinal fracture

Interventions

Control group:none
Test group:Controlled hypotension with pump infusion of remifentanil

Sponsors

Department of Anesthesiology, Changdu People's Hospital of Xizang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18-75 years old, ASA I-III; 2. Plateau (altitude >= 2500 meters) permanent residents (residence time > 6 months); 3. Planned major orthopedic surgery: hip / knee replacement, femur / tibiofibula reduction and internal fixation, spinal fusion (operation duration is expected to be >= 2 hours).

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular and cerebrovascular disease (EF 133 µ mol/l); 3. Uncontrolled hypertension (preoperative systolic blood pressure > 180 mmHg); 4. Coagulation dysfunction (INR > 1.5, platelet < 100 × 10^9 /l); 5. Severe respiratory disease (preoperative spo2 < 90%).

Design outcomes

Primary

MeasureTime frame
Bleeding volume;

Secondary

MeasureTime frame
Urine output;lactic acid;

Countries

China

Contacts

Public ContactLei Zou

Department of Anesthesiology, Changdu People's Hospital of Xizang

zoulei4038@163.com+86 138 8372 5550

Outcome results

None listed

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