Anesthesia, Lung Cancer, Progression, Disease
Conditions
Keywords
Propofol, Sevoflurane, Lung Cancer, VATS
Brief summary
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.
Detailed description
Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1\ 2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.
Interventions
DRUGPropofol
The propofol group was both induced and maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system.
DRUGSevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6-month overall survival, 1-year overall survival, and 3-year overall survival |
| The presence of disease progression | From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Karnofsky performance status score | 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 | to access patients' functional impairment |
| Postoperative complications | The period from the day of surgery to postoperative 30 days | Clavien-Dindo classification, and other postoperative complications |
| Length of hospital stays | from the day of surgery to dischage, assessed up to 30 days | the length of stays in general ward and ICU |
Other
| Measure | Time frame | Description |
|---|---|---|
| blood loss | during the operation of VATS | record the blood loss (ml) |
| volume of blood transfusion | during the operation of VATS | volume of blood transfusion (ml) |
| time of operation and anesthesia | time of the total procedure | record the time the opeartion and anesthesia |
Countries
Taiwan
Contacts
Primary ContactHung-Te Hsu, MD
Outcome results
None listed