Status:
COMPLETED
Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery
Lead Sponsor:
Hao Long
Collaborating Sponsors:
Sun Yat-sen University School of Art
Sun Yat-sen University Department of Psychology
Conditions:
Analgesia
Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
To explore the feasibility and effectiveness of Perioperative Music Therapy Plus Oxycodone in pain management after thoracic surgery, patients will be randomly assigned into two groups. The experiment...
Eligibility Criteria
Inclusion
- Enhanced CT or PET/CT indicate primary malignant pulmonary nodule;
- The clinical stage belongs to cT1-4N0-2M0 before treatment or ycT1-4N0-2M0 after neoadjuvant treatment (AJCC/TNM 8th Edition);
- Suitable for video-assisted thoracoscopic surgery after evaluated by thoracic surgeon;
- FEV1 \> 1.5L and DLCO \> 60% pred;
- Hearing loss lesser than 35 decibels (dB) in the better hearing ear;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
- American Society of Anesthesiologists Score of 1 or 2;
- Confirmed eligibility for R0 resection for curative intent by thoracic surgeon assessment;
- Adequate cardiopulmonary function, confirmed to meet the requirement for surgical resection for curative intent;
- Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;
- Life expectancy greater than 12 months
Exclusion
- Enhanced CT or PET/CT indicate metastatic malignant pulmonary nodule;
- Hearing loss greater than 35 decibels (dB) in the better hearing ear;
- Active autoimmune disease or history of autoimmune disease that may recur; Note: well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid hormone replacement only); well-controlled celiac disease; skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is not expected to recur in the absence of an external trigger.
- History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease;
- Serious infection occurred before grouping, including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; severe chronic or active infection (including pulmonary tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;
- Simultaneous participation in another therapeutic clinical study;
- Pregnant or lactating women, or male and female patients planning to have children during the study;
- Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05981924
Start Date
August 1 2023
End Date
April 20 2024
Last Update
July 17 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000