NCT05926336 The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action
| NCT ID | NCT05926336 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kaohsiung Medical University Chung-Ho Memorial Hospital |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,316 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,316 participants in total. It began in 2023-05-23 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
1. Eligible participants were assessed prior to anesthesia. After the patient is admitted to the hospital, the subject's consent form is explained, and the consent form must be signed before the operation. 2. This is a two-arm, parallel-group randomized clinical trial.In the preoperative waiting area, the patients are randomly assigned and divided into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. 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. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). 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 (KPS) score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), ASA physical status scores, tumor marker ,tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, 3-year and 5-year overall survival and Karnofsky performance status score were recorded.
Eligibility Criteria
Inclusion Criteria: * eighteen to eighty-year-old * ASA class I-III patients * Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia Exclusion Criteria: * Severe 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 brain, liver, lungs, ovarian cancer、cell carcinoma or other metastatic.
Contact & Investigator
Zhi-Fu Wu
PRINCIPAL INVESTIGATOR
Kaohsiung Medical University
Frequently Asked Questions
Who can join the NCT05926336 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05926336 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05926336 currently recruiting?
Yes, NCT05926336 is actively recruiting participants. Contact the research team at aneswu@gmail.com for enrollment information.
Where is the NCT05926336 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT05926336 clinical trial?
NCT05926336 is sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. The principal investigator is Zhi-Fu Wu at Kaohsiung Medical University. The trial plans to enroll 1,316 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.