Trial Title:
The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action
NCT ID:
NCT05926336
Condition:
Lung Cancer
Brain Tumor
Liver Cancer
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Anesthetics
Propofol
Sevoflurane
Conditions: Keywords:
Propofol
Sevoflurane
Survival
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Propofol
Description:
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.
Arm group label:
Propofol
Other name:
total intravenous anesthesia
Intervention type:
Drug
Intervention name:
Sevoflurane
Description:
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target
minimum alveolar concentration of 0.7-1.3 MAC)
Arm group label:
Sevoflurane
Other name:
inhalation anesthesia
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Zhi-Fu Wu
Start date:
May 23, 2023
Completion date:
July 2026
Lead sponsor:
Agency:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Agency class:
Other
Source:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05926336
