Clinical trial NCT05663242: The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lung Cancer
Progression, Disease
Anesthesia
Keywords: Propofol
Sevoflurane
Lung Cancer
VATS
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Overall survival
timeFrame: 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
measure: The presence of disease progression
timeFrame: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
Secondary outcomes:
measure: Postoperative complications
timeFrame: The period from the day of surgery to postoperative 30 days
measure: Karnofsky performance status score
timeFrame: 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
measure: Length of hospital stays
timeFrame: from the day of surgery to dischage, assessed up to 30 days
Other outcomes:
measure: time of operation and anesthesia
timeFrame: time of the total procedure
measure: blood loss
timeFrame: during the operation of VATS
measure: volume of blood transfusion
timeFrame: during the operation of VATS
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References: