Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926336
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-05-26
Brief Title:
The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Eligible participants were assessed prior to anesthesia After the patient is admitted to the hospital the subjects consent form is explained and the consent form must be signed before the operation
2 This is a two-arm parallel-group randomized clinical trialIn the preoperative waiting area the patients are randomly assigned and divided into two groups according to the allocation sequence table corresponding to 11 randomization generated by the computer The propofol group was both induced and maintained at an effect-site concentration Ce of 20-40 mcgmL by a target-controlled infusion TCI system The sevoflurane group was maintained via sevoflurane vaporizer between 1 and 3 target minimum alveolar concentration of 07-13 During the operation the dose of anesthetic drugs propofolfentanyl remifentanil and sevofluranecisatracuriumrocuronium 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 losstransfusion duration of surgery duration of anesthesia total opioid remifentanilfentanyl 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
2 This is a two-arm parallel-group randomized clinical trialIn the preoperative waiting area the patients are randomly assigned and divided into two groups according to the allocation sequence table corresponding to 11 randomization generated by the computer The propofol group was both induced and maintained at an effect-site concentration Ce of 20-40 mcgmL by a target-controlled infusion TCI system The sevoflurane group was maintained via sevoflurane vaporizer between 1 and 3 target minimum alveolar concentration of 07-13 During the operation the dose of anesthetic drugs propofolfentanyl remifentanil and sevofluranecisatracuriumrocuronium 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 losstransfusion duration of surgery duration of anesthesia total opioid remifentanilfentanyl 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 losstransfusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None