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How does the usage of steroids affect the postoperative prognosis of patients undergoing surgery for intradural spinal cord tumors?

The efficacy of steroid usage in patients undergoing surgery for intradural spinal cord tumors: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0009467
Enrollment
56
Registered
2024-05-24
Start date
2024-07-24
Completion date
Unknown
Last updated
2024-07-23

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

Conditions

None listed

Interventions

Drug : For the treatment group: Dexamethasone will be administered. After randomization, patients in the treatment group will receive two doses of dexamethasone within 1 hour before surgery and 12 hou

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Adults aged 19 years and above (2) Patients diagnosed with neurofibroma or meningioma within the thoracic spinal cord (3) Patients capable of walking with a muscle strength of 3 or higher on the Medical Research Council (MRC) scale for lower limbs (4) Patients willing to participate in the study, adhere to treatment and procedures, and visit the hospital for all follow-up evaluations (5) Patients who have received explanations regarding the purpose, methods, and effects of the study and have voluntarily signed the informed consent form

Exclusion criteria

Exclusion criteria: (1) Patients who are either under 18 years of age or 66 years of age and older (2) Patients deemed by the investigator to be ineligible for spinal surgery under general anesthesia due to significant cardiovascular, pulmonary, hepatic, or renal dysfunction (3) Patients with diabetes mellitus (4) Patients with gastrointestinal disorders including gastritis and gastric ulcers (5) Patients with hypersensitivity reactions or adverse effects to steroids (6) Patients with infections in joint spaces, bursae, tendon sheaths, or around tendons (7) Patients receiving live bacterial vaccines (8) Patients with herpes simplex, herpes zoster, or chickenpox (9) Patients with infections where effective antimicrobial therapy is not available or systemic fungal infections (10) Patients receiving immunosuppressive therapy (11) Patients requiring reoperation due to recurrence of existing tumors (12) Patients diagnosed with neurofibromatosis (13) Patients with neurofibromas showing a dumbbell tumor pattern invading the neural foramina (14) Pregnant or lactating women (15) Patients with cognitive impairment making communication with medical staff and completion of surveys difficult

Design outcomes

Secondary

MeasureTime frame
Neurological evaluation of patients: mJOA (modified Japanese orthopedic association) score for thoracic myelopathy, Modified McCormick scale, ASIA scale (American Spinal Injury Association) ;Assessment of pain severity in patients: Pain DETECT Questionnaire, SF-MPQ (Short-form McGill Pain Questionnaire), LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) pain scale;Assessment of quality of life in patients: EQ-5D (EuroQol-5Dimention), SF-36 (Short Form-36);Evaluation of activities of daily living in patients: SCIM III (Spinal Cord Independence Measure III);Complete resection of tumor post-surgery through magnetic resonance imaging (MRI) scans;Presence of spinal cord signal change through magnetic resonance imaging (MRI) scans;Adverse event

Primary

MeasureTime frame
Assessment of pain severity in patients using the Korean Neuropathic Pain Questionnaire (KNPQ)

Countries

Korea, Republic of

Contacts

Public ContactYunJung Kim

Asan Medical Center

yunjung.kim@amc.seoul.kr+82-2-3010-7190

Outcome results

None listed

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