Lung Cancer Clinical Trial
Official title:
To Compare the Effects of Intraoperative Use of Intravenous Anesthetics Propofol and Inhaled Anesthetics Sevoflurane on the Prognosis of Patients Undergoing Surgery for Primary Lung Tumors and the Investigation of Its Mechanism of Action.
This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary early lung cancer. The study will enroll approximately 300 volunteers to compare the progression-free or overall survival in patients undergoing video-assisted thoracoscopic surgery (VATS) for primary lung tumors between propofol and sevoflurane for the maintenance of anesthesia.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | November 30, 2026 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - eighteen to eighty-year-old - ASA class I-III patients - Received elective thoracic surgery for primary lung tumors under general anesthesia Exclusion Criteria: - mental disorder - poor liver function - pregnant or lactating women - morbidly obese - allergy to any of the drugs used in this study - recurrent tumor or repeat surgery - biopsy cases - incomplete outcome-data - palliative treatment after surgery - simultaneous treatment of other malignancies - emergency surgery - presence of other malignant tumors - combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine - diagnosed as benign lung tumor, or other metastatic lung tumor |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Medical University Chung-Ho Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | time of operation and anesthesia | record the time the opeartion and anesthesia | time of the total procedure | |
Other | blood loss | record the blood loss (ml) | during the operation of VATS | |
Other | volume of blood transfusion | volume of blood transfusion (ml) | during the operation of VATS | |
Primary | Overall survival | 6-month overall survival, 1-year overall survival, and 3-year overall survival | From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | |
Primary | The presence of disease progression | From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months | From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months | |
Secondary | Postoperative complications | Clavien-Dindo classification, and other postoperative complications | The period from the day of surgery to postoperative 30 days | |
Secondary | Karnofsky performance status score | to access patients' functional impairment | Karnofsky performance score(from 0 (dead) to 100(normal no complication)) before surgery (baseline data) , postoperation 7 days, postoperation 3 months, postoperation 6 months, postoperation 12 months | |
Secondary | Length of hospital stays | the length of stays in general ward and ICU | from the day of surgery to dischage, assessed up to 30 days |
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