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RecruitingNCT05926336Updated Sep 28, 2023

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

A Phase 4 interventional study of Propofol and Sevoflurane in Lung Cancer, Brain Tumor and Liver Cancer, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
1,316
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.
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.

02

Conditions studied

  • Lung Cancer
  • Brain Tumor
  • Liver Cancer
  • Ovarian Cancer

Keywords

  • Propofol
  • Sevoflurane
  • Survival
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 1,316 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,316 participants (estimated)

Study arms

  • Experimental
    Sevoflurane

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

    Drug: Sevoflurane

  • Experimental
    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.

    Drug: Propofol

Interventions

  • DrugPropofol

    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.

    Also known as: total intravenous anesthesia

  • DrugSevoflurane

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

    Also known as: inhalation anesthesia

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. Postoperative complications

    Clavien-Dindo classification, and other postoperative complications

    Time frame: The period from the day of surgery to postoperative 30 days

  2. 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.

    Time frame: postoperation 6 months, postoperation 12 months,postoperation 36 months.

  3. 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

  1. time of operation and anesthesia

    record the time the opeartion and anesthesia

    Time frame: from start to end of the procedure

  2. blood loss

    record the blood loss (ml)

    Time frame: from start to end of the procedure

  3. volume of blood transfusion

    volume of blood transfusion (ml)

    Time frame: from start to end of the procedure

07

Study locations

1 of 1 sites recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, Taiwan
    • Zhi-Fu Wu · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05926336
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Jul 3, 2023
Start date
May 23, 2023
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Sep 28, 2023

Study contacts

Zhi-Fu Wu, MD
Contact
aneswu@gmail.com
07-3121101 ext. 7035
Zhi-Fu Wu
principal investigator · Kaohsiung Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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