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.
Overview
- Phase
- Phase 4
- Intervention
- Sevoflurane
- Conditions
- Lung Cancer
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Sevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3).
Intervention: Sevoflurane
Propofol
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.
Intervention: Propofol
Outcomes
Primary Outcomes
Overall survival
Time Frame: 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
Time Frame: 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 Outcomes
- Postoperative complications(The period from the day of surgery to postoperative 30 days)
- Length of hospital stays(from the day of surgery to dischage, assessed up to 30 days)
- 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)