Lung CancerPhase 4NCT05926336
The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action
A Phase 4 study testing Propofol and Sevoflurane in people with Lung Cancer and Brain Tumor, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lung Cancer, Brain Tumor, Liver Cancer
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,316 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 May 2023to Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eighteen to eighty-year-old
- ASA class I-III patients
- Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Zhi-Fu Wu
About this study
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 Brain, Liver, Lung, and Ovarian Cancer Tumors and the Investigation of Its Mechanism of Action
- 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.
- 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.
Read the detailed description
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, 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 scoress, tumor marker , 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.
- Conditions
- Lung Cancer, Brain Tumor, Liver Cancer, Ovarian Cancer
- Being tested
- Propofol, Sevoflurane
- Keywords
- Propofol, Sevoflurane, Survival
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms, Liver Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called total intravenous anesthesia
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.
SevofluraneDrug
Also called inhalation anesthesia
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). Receives: Drug: Sevoflurane |
| Propofol | Experimental | 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
6-month overall survival, 1-year overall survival, and 3-year overall survival
Measured: 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
Measured: From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months
Secondary outcomes (3)
Postoperative complications
Clavien-Dindo classification, and other postoperative complications
Measured: The period from the day of surgery to postoperative 30 days
Karnofsky performance status score
Karnofsky performance score, from 100 to 0, where 100 is perfect health and 0 is death. The lower the Karnofsky performance score, the worse the likelihood of survival.
Measured: postoperation 6 months, postoperation 12 months,postoperation 36 months.
Length of hospital stays
the length of stays in general ward and ICU
Measured: from the day of surgery to dischage, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start23 May 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,316 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi-Fu Wu, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926336
- Sponsor's protocol ID
- KMUHIRB-F(I)-20230075
- Status last verified
- May 2023
- First submitted
- 26 May 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Brain, Liver, Lung, and Ovarian Cancer Tumors and the Investigation of Its Mechanism of Action
- ClinicalTrials.gov ID
- NCT05926336
- Acronym / sponsor ID
- KMUHIRB-F(I)-20230075
- Conditions
- Lung Cancer, Brain Tumor, Liver Cancer, Ovarian Cancer
- Keywords
- Propofol, Sevoflurane, Survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,316 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Detailed description
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, 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 scoress, tumor marker , 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: SevofluraneThe sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). |
| Propofol | Experimental | Drug: PropofolThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- eighteen to eighty-year-old
- ASA class I-III patients
- Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: total intravenous anesthesiaThe 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. | Drug | Propofol |
| SevofluraneAlso: inhalation anesthesiaThe sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC) | Drug | Sevoflurane |
Primary outcome
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
3 secondary outcomes
Postoperative complications
Time frame: The period from the day of surgery to postoperative 30 days
Karnofsky performance status score
Time frame: postoperation 6 months, postoperation 12 months,postoperation 36 months.
Length of hospital stays
Time frame: from the day of surgery to dischage, assessed up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Fu Wu principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Sevoflurane in people with Lung Cancer and Brain Tumor, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Fu Wu, MD (07-3121101 ext. 7035, aneswu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.