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To evaluate the clinical effectiveness of PDCA circulation combined with neuronavigational system in improving perioperative coordination in patients undergoing craniocerebral surgery: a multicenter, randomized, open-label, parallel-controlled clinical trial

To evaluate the clinical effectiveness of PDCA circulation combined with neuronavigational system in improving perioperative coordination in patients undergoing craniocerebral surgery: a multicenter, randomized, open-label, parallel-controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027105
Enrollment
Unknown
Registered
2019-10-31
Start date
2020-07-01
Completion date
Unknown
Last updated
2019-11-04

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

Conditions

Perioperative period of craniocerebral surgery

Interventions

experimental group:PDCA
control group:Traditional preoperative education

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The newly treated patient had no previous history of craniocerebral disease; 2. Aged 18-60 years; 3. Male or non-pregnant or lactating female; 4. Good nutritional status, albumin >= 35 g/L, hemoglobin >= 100 g/L; 5. The viscera function was good, and biochemical examination met the following conditions: ALT <= 2.5x the upper limit of normal value (ULN), AST <= 2.5x ULN, serum total bilirubin <= 1.5xULN, serum creatinine <= 1.5x ULN; 6. Be conscious and able to cooperate with investigation. 7. Sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Surgical contraindications; 2. Long-term use of immunosuppressive drugs or steroids; 3. Patients with severe or uncontrolled medical conditions and infected patients (including atrial fibrillation, angina, and heart disease: functional insufficiency, ejection fraction lower than 50%, difficult to control hypertension, COPD, etc.); 4. Patients who are obese or drink excessively; 5. Patients with severe or uncontrollable mental illness; 6. Drug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or the assessment of the results had an impact; 7. A history of serious mental illness; 8. Extensive tumor metastasis, expected life span < 6 months; 9. Participated in other clinical trials within the last three months.

Design outcomes

Primary

MeasureTime frame
Perioperative coordination;

Secondary

MeasureTime frame
Knowledge rate of surgical preparation;Degree of anxiety in surgical patients;complication rates;

Countries

China

Contacts

Public ContactLili Ye

Zhujiang Hospital of Southern Medical University

277867983@qq.com+86 13512713425

Outcome results

None listed

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