The Effects of Using Different Anesthetics on the Prognosis of Primary Lung Tumors and Its Mechanism of Action

ConditionsLung Cancer Progression, Disease Anesthesia

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age20-80

SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

eighteen to eighty-year-old

ASA class I-III patients

Received elective thoracic surgery for primary lung tumors under general anesthesia

Disqualifiers

mental disorder

poor liver function

pregnant or lactating women

morbidly obese

Trial design

Design model

Parallel

Treatments tested in this trial

Propofol
Drug
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.
Sevoflurane
Drug
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: SevofluraneExperimental treatment 1 intervention

Group B: PropofolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Overall survival

6-month overall survival, 1-year overall survival, and 3-year 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

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

Time frame

From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months

Secondary outcomes

Postoperative complications

Clavien-Dindo classification, and other postoperative complications

Time frame

The period from the day of surgery to postoperative 30 days

Karnofsky performance status score

to access patients' functional impairment

Time frame

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

Length of hospital stays

the length of stays in general ward and ICU

Time frame

from the day of surgery to dischage, assessed up to 30 days

Other outcomes

time of operation and anesthesia

record the time the opeartion and anesthesia

Time frame

time of the total procedure

blood loss

record the blood loss (ml)

Time frame

during the operation of VATS

volume of blood transfusion

volume of blood transfusion (ml)

Time frame

during the operation of VATS

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaohsiung Medical University Chung-Ho Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov

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