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Study on the Effects of Oliceridine on Postoperative Analgesia, Immune Function, and Postoperative Delirium in Elderly Patients Undergoing Spinal Tuberculosis Surgery

Study on the Effects of Oliceridine on Postoperative Analgesia, Immune Function, and Postoperative Delirium in Elderly Patients Undergoing Spinal Tuberculosis Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115441
Enrollment
Unknown
Registered
2025-12-26
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Postoperative Pain, Immunological Status, and Delirium in Patients Following Spinal Tuberculosis Surgery

Interventions

Sufentanil group:Postoperative continuous analgesia with Sufentanil.
Oliceridine group:Postoperative continuous analgesia with Oliceridine.

Sponsors

Hebei Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 60–80 years, regardless of gender, diagnosed with spinal tuberculosis by imaging and pathological examination of lesion specimens, with confirmed exclusion of non-tuberculous mycobacterial infection, and scheduled for elective surgical treatment; 2. ASA physical status I–III; 3. Preoperative Mini-Mental State Examination (MMSE) score >=24; 4. Informed of the study content and objectives, voluntarily participating in the study, and having signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe cardiopulmonary dysfunction, hepatic or renal insufficiency (Child-Pugh Class C, estimated glomerular filtration rate [eGFR] 50 mL/day. Known allergy or contraindication to opioid medications (e.g., sufentanil, oliceridine). Pregnancy or lactation. Participation in another clinical trial within 1 month prior to surgery. Cognitive or language impairment that would preclude compliance with study assessments. History of drug or alcohol dependence.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;

Secondary

MeasureTime frame
S100ß protein and neuron-specific enolase;Postoperative delirium incidence rate;Percentage of CD3+ (cells);Nausea and vomiting, respiratory depression, abdominal distension, constipation, dizziness, pruritus.;CD4+/CD8+ ratio;Percentage of CD4+ (cells);IL-10, IL-6, TNF-a, IFN-? ;Patient's cognitive status at discharge;

Countries

China

Contacts

Public ContactZhao Zijun

Hebei Chest Hospital

86231721@qq.com+86 311 86911232

Outcome results

None listed

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