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Effect of perioperative nebulized inhalation of budesonide and L-Cysteine on pulmonary complications in patients with tumors of the Posterior Skull Base

Effect of perioperative nebulized inhalation of budesonide and L-Cysteine on pulmonary complications in patients with tumors of the Posterior Skull Base

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032022
Enrollment
Unknown
Registered
2020-04-17
Start date
2020-04-30
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

Tumor of Posterior Skull Base

Interventions

experimental group:Preoperative and postoperative nebulizations were performed 3 days after surgery. Budesonide 2ml bid, L-cysteine 3ml bid and terbutaline 2ml bid, and the rest were treated routinely
control group:Preoperative and postoperative nebulizations were performed 3 days after surgery. Normal saline 5ml bid and terbutaline 2ml bid, and the rest were treated routinely.

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged > 65 years. 2. Smoking history, at least 2 weeks before the operation, and the following conditions: (1) Aged >= 75 years; (2) Smoking Index >= 800 years; (3) Severe chronic obstructive pulmonary disease (COPD) or sputum culture positive for pathogenic tracheal colonization bacteria. 3. Critical state of pulmonary function or low pulmonary function: (1) Volume of air in the first second (FEV1) & Lt; 1.0 l; (2) Acosog Z4099 / RTOG STANDARD: one-second rate (FEV1%)50%-60% , aged > 75 years, pulmonary oxygen diffusivity (DLCO) 50%-60%; (3) American Society of Clinical Pharmacy (ACCP) Standard: predicted FEV1 postoperatively = 28kg / M2 or body surface area (BSA) >= 1.68M2. 6. History of underlying and Associated Diseases: COPD, asthma, pulmonary surgery, thoracic deformity, tuberculosis and other pulmonary diseases, such as pulmonary fibrosis. 7. Other heart, liver, kidney and other functional disorders and Metabolic Diseases (such as diabetes) and various causes of malnutrition or anemia, etc..

Exclusion criteria

Exclusion criteria: 1. Aged > 85 years; 2. History of Malignancy; 3. Use of immunosuppressive drug or immunodeficiency disease; 4. Pulmonary infection within weeks.

Design outcomes

Primary

MeasureTime frame
Incidence of pulmonary complications;

Secondary

MeasureTime frame
Incidence of intubation or tracheotomy;average length of hospital stay and average cost.;

Countries

China

Contacts

Public ContactLan Zhigang

Neurosurgery, West China Hospital of Sichuan University

158075478@qq.com+86 18908064671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026