Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873479
Status:
UNKNOWN
Last Update Posted:
2021-08-31
First Post:
2021-04-30
Brief Title:
Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery
Sponsor:
Tianjin Nankai Hospital
Organization:
Tianjin Nankai Hospital
Study Overview
Official Title:
Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgerya Single Center Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
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:
This study is a randomized double-blinded controlled design In this study low doses of S-ketamine were selected for surgury treatment in septic patients under general anesthesia Meanwhile activity of HO-1 protein oxidative stress and inflammatory markers in serum are measured to evaluating the effects of S-ketamine Anesthetic on inflammatory response in septic patients undergoing abdominal surgury In additionIt is very necessary to make use of the advantages of low-dose S-ketamine in anti-inflammation and avoid the side effects of mental symptoms so as to guide the new direction of perioperative clinical application of S-ketamine
Detailed Description:
1 Title Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery
2 Research center Single Center
3 The Design of the study Randomizeddouble-blind Controlled Trial
4 The population of the study The main inclusion criteria are 18 years old or abovePatients with sepsis who need surgical treatment under general anesthesia and should be transferred to ICU for further treatment after surgery
5 Sample size Enroll 50 patients 25 patients in each group
6 Interventions Participants in the test group received midazolam 005-01mg kg sufentanil 01-02ugkgEtomidate 01-02mgkg cisatracurium 015-03mgkg S-ketamine 0125mgkg low dose for Anesthesia induction followed by an infusion of remifentanil 005-015ugkgmin and S-Ketamine 0125mgkgh low dose and continuous inhalation of sevoflurane at 2-3
while participants in the control group was the same as the test group except for received the same volume of saline instead of S-ketamine
Intraoperative cisatracurium and sufentanil were added according to the circumstancesBispectral index BIS was used to monitor the depth of anesthesia in two groups and the BIS value was controlled to be 40-60 and the dose was adjusted according to the depth of anesthesia
7 The aim of the research To investigate the effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery
8 Outcome 1 Primary outcome the incidence of postoperative pulmonary complications 2Secondary outcomeInflammatory indicators leukocyte CRP PCT levelsInflammatory factors IL-6 TNF-α CC-16activity of HO-1Imaging diagnosissuch as chest X-rayultrasoundtherapies for respiratory insufficiencysuch as nasal cannulaface maskpostoperative noninvasive ventilation re-intubation with postoperative mechanical ventilationIncidence of postoperative adverse reactions such as restlessness delirium salivation nausea vomiting respiratory depression dizziness etcLength of stay in ICU
9 The estimated duration of the study1-2years
2 Research center Single Center
3 The Design of the study Randomizeddouble-blind Controlled Trial
4 The population of the study The main inclusion criteria are 18 years old or abovePatients with sepsis who need surgical treatment under general anesthesia and should be transferred to ICU for further treatment after surgery
5 Sample size Enroll 50 patients 25 patients in each group
6 Interventions Participants in the test group received midazolam 005-01mg kg sufentanil 01-02ugkgEtomidate 01-02mgkg cisatracurium 015-03mgkg S-ketamine 0125mgkg low dose for Anesthesia induction followed by an infusion of remifentanil 005-015ugkgmin and S-Ketamine 0125mgkgh low dose and continuous inhalation of sevoflurane at 2-3
while participants in the control group was the same as the test group except for received the same volume of saline instead of S-ketamine
Intraoperative cisatracurium and sufentanil were added according to the circumstancesBispectral index BIS was used to monitor the depth of anesthesia in two groups and the BIS value was controlled to be 40-60 and the dose was adjusted according to the depth of anesthesia
7 The aim of the research To investigate the effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery
8 Outcome 1 Primary outcome the incidence of postoperative pulmonary complications 2Secondary outcomeInflammatory indicators leukocyte CRP PCT levelsInflammatory factors IL-6 TNF-α CC-16activity of HO-1Imaging diagnosissuch as chest X-rayultrasoundtherapies for respiratory insufficiencysuch as nasal cannulaface maskpostoperative noninvasive ventilation re-intubation with postoperative mechanical ventilationIncidence of postoperative adverse reactions such as restlessness delirium salivation nausea vomiting respiratory depression dizziness etcLength of stay in ICU
9 The estimated duration of the study1-2years
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