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Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery

Primary Purpose

Sepsis, Acute Lung Injury

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
S-ketamine
saline
Sponsored by
Tianjin Nankai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring sepsis, acute lung injury, S-ketamine, Inflammation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with sepsis requiring surgical treatment under general anesthesia should be transferred to ICU with endotracheal intubation for further treatment after surgery
  • 18≤ age ≤85, gender and nationality is not limited
  • Agree to participate in this study and sign the informed consent

Exclusion Criteria:

  • Declined to participate in this study
  • Patients in pregnancy or with drug allergy in this study
  • Patient had chronic or acute respiratory ailments
  • long-term preoperative continuous ventilatory support or oxygen dependency
  • Patients are now being included in another study
  • In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study

Sites / Locations

  • Tianjin Nankai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

test group

control group

Arm Description

Participants in the test group received midazolam 0.05-0.1mg /kg, sufentanil 0.1-0.2ug/kg,Etomidate 0.1-0.2mg/kg, cisatracurium 0.15-0.3mg/kg, S-ketamine 0.125mg/kg (low dose) for Anesthesia induction, followed by an infusion of remifentanil 0.05-0.15ug/kg/min and S-Ketamine 0.125mg/kg/h (low dose) and continuous inhalation of sevoflurane at 2-3%.

Participants in the control group received midazolam 0.05-0.1mg /kg, sufentanil 0.2-0.3ug/kg,Etomidate 0.2-0.3mg/kg, cisatracurium 0.15-0.3mg/kg, saline 0.125ml/kg for Anesthesia induction, followed by an infusion of remifentanil 0.1-0.3ug/kg/min and saline 0.125ml/kg/h and continuous inhalation of sevoflurane at 2-3%.

Outcomes

Primary Outcome Measures

the incidence of postoperative pulmonary complications
such as pneumonia,atelectasis ,pleural effusion,respiratory insufficiency,etc

Secondary Outcome Measures

Inflammatory indicators: leukocyte, CRP, PCT levels
leukocyte, CRP, PCT levels
Inflammatory factors
IL-6, TNF-α, CC-16,activity of HO-1
imaging diagnosis
chest X-ray,ultrasound
therapies for respiratory insufficiency
nasal cannula,face mask,postoperative noninvasive ventilation, re-intubation with postoperative mechanical ventilation
Incidence of postoperative adverse reactions
such as restlessness, delirium, salivation, nausea, vomiting, respiratory depression, dizziness, etc
Length of stay in ICU
The time from the patient's surgery to leave the ICU
Opioid consumption
consumption of sufentanil and remifentanil

Full Information

First Posted
April 30, 2021
Last Updated
August 30, 2021
Sponsor
Tianjin Nankai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04873479
Brief Title
Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery
Official Title
Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery:a Single Center, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Nankai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 addition,It 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
Title: Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery Research center: Single Center The Design of the study: Randomized,double-blind, Controlled Trial The population of the study: The main inclusion criteria are 18 years old or above,Patients with sepsis who need surgical treatment under general anesthesia and should be transferred to ICU for further treatment after surgery Sample size: Enroll 50 patients (25 patients in each group) Interventions: Participants in the test group received midazolam 0.05-0.1mg /kg, sufentanil 0.1-0.2ug/kg,Etomidate 0.1-0.2mg/kg, cisatracurium 0.15-0.3mg/kg, S-ketamine 0.125mg/kg (low dose) for Anesthesia induction, followed by an infusion of remifentanil 0.05-0.15ug/kg/min and S-Ketamine 0.125mg/kg/h (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 circumstances.Bispectral 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. The aim of the research: To investigate the effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery Outcome# 1) Primary outcome# the incidence of postoperative pulmonary complications 2)Secondary outcome#Inflammatory indicators: leukocyte, CRP, PCT levels;Inflammatory factors: IL-6, TNF-α, CC-16,activity of HO-1;Imaging diagnosis,such as chest X-ray,ultrasound;therapies for respiratory insufficiency,such as nasal cannula,face mask,postoperative noninvasive ventilation, re-intubation with postoperative mechanical ventilation;Incidence of postoperative adverse reactions such as restlessness, delirium, salivation, nausea, vomiting, respiratory depression, dizziness, etc;Length of stay in ICU The estimated duration of the study#1-2years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Acute Lung Injury
Keywords
sepsis, acute lung injury, S-ketamine, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
test group
Arm Type
Experimental
Arm Description
Participants in the test group received midazolam 0.05-0.1mg /kg, sufentanil 0.1-0.2ug/kg,Etomidate 0.1-0.2mg/kg, cisatracurium 0.15-0.3mg/kg, S-ketamine 0.125mg/kg (low dose) for Anesthesia induction, followed by an infusion of remifentanil 0.05-0.15ug/kg/min and S-Ketamine 0.125mg/kg/h (low dose) and continuous inhalation of sevoflurane at 2-3%.
Arm Title
control group
Arm Type
Other
Arm Description
Participants in the control group received midazolam 0.05-0.1mg /kg, sufentanil 0.2-0.3ug/kg,Etomidate 0.2-0.3mg/kg, cisatracurium 0.15-0.3mg/kg, saline 0.125ml/kg for Anesthesia induction, followed by an infusion of remifentanil 0.1-0.3ug/kg/min and saline 0.125ml/kg/h and continuous inhalation of sevoflurane at 2-3%.
Intervention Type
Drug
Intervention Name(s)
S-ketamine
Intervention Description
Participants in the test group received midazolam 0.05-0.1mg /kg, sufentanil 0.1-0.2ug/kg,Etomidate 0.1-0.2mg/kg, cisatracurium 0.15-0.3mg/kg, S-ketamine 0.125mg/kg (low dose) for Anesthesia induction, followed by an infusion of remifentanil 0.05-0.15ug/kg/min and S-Ketamine 0.125mg/kg/h (low dose) and continuous inhalation of sevoflurane at 2-3%.
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
Participants in the control group received midazolam 0.05-0.1mg /kg, sufentanil 0.1-0.2ug/kg,Etomidate 0.1-0.2mg/kg, cisatracurium 0.15-0.3mg/kg, saline 0.125ml/kg for Anesthesia induction, followed by an infusion of remifentanil 0.05-0.15ug/kg/min and saline 0.125ml/kg/h and continuous inhalation of sevoflurane at 2-3%.
Primary Outcome Measure Information:
Title
the incidence of postoperative pulmonary complications
Description
such as pneumonia,atelectasis ,pleural effusion,respiratory insufficiency,etc
Time Frame
an average of 1 week
Secondary Outcome Measure Information:
Title
Inflammatory indicators: leukocyte, CRP, PCT levels
Description
leukocyte, CRP, PCT levels
Time Frame
an average of 1 day
Title
Inflammatory factors
Description
IL-6, TNF-α, CC-16,activity of HO-1
Time Frame
an average of 1 day
Title
imaging diagnosis
Description
chest X-ray,ultrasound
Time Frame
an average of 1 week
Title
therapies for respiratory insufficiency
Description
nasal cannula,face mask,postoperative noninvasive ventilation, re-intubation with postoperative mechanical ventilation
Time Frame
an average of 1 week
Title
Incidence of postoperative adverse reactions
Description
such as restlessness, delirium, salivation, nausea, vomiting, respiratory depression, dizziness, etc
Time Frame
an average of 1 week
Title
Length of stay in ICU
Description
The time from the patient's surgery to leave the ICU
Time Frame
an average of 1 month
Title
Opioid consumption
Description
consumption of sufentanil and remifentanil
Time Frame
an average of 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with sepsis requiring surgical treatment under general anesthesia should be transferred to ICU with endotracheal intubation for further treatment after surgery 18≤ age ≤85, gender and nationality is not limited Agree to participate in this study and sign the informed consent Exclusion Criteria: Declined to participate in this study Patients in pregnancy or with drug allergy in this study Patient had chronic or acute respiratory ailments long-term preoperative continuous ventilatory support or oxygen dependency Patients are now being included in another study In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianbo Yu MD PhD
Phone
86-22-27435873
Email
yujianbo11@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianbo Yu MD PhD
Organizational Affiliation
Tianjin Nankai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Nankai Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Jianbo, Professor
Phone
(022)27435008
Ext
(022)27435027
Email
yujianbo11@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29322377
Citation
Trimmel H, Helbok R, Staudinger T, Jaksch W, Messerer B, Schochl H, Likar R. S(+)-ketamine : Current trends in emergency and intensive care medicine. Wien Klin Wochenschr. 2018 May;130(9-10):356-366. doi: 10.1007/s00508-017-1299-3. Epub 2018 Jan 10. Erratum In: Wien Klin Wochenschr. 2018 Sep;130(17-18):557.
Results Reference
background
PubMed Identifier
27829093
Citation
Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.
Results Reference
background
PubMed Identifier
29945898
Citation
Zanos P, Moaddel R, Morris PJ, Riggs LM, Highland JN, Georgiou P, Pereira EFR, Albuquerque EX, Thomas CJ, Zarate CA Jr, Gould TD. Ketamine and Ketamine Metabolite Pharmacology: Insights into Therapeutic Mechanisms. Pharmacol Rev. 2018 Jul;70(3):621-660. doi: 10.1124/pr.117.015198. Erratum In: Pharmacol Rev. 2018 Oct;70(4):879.
Results Reference
background
PubMed Identifier
21138901
Citation
Welters ID, Feurer MK, Preiss V, Muller M, Scholz S, Kwapisz M, Mogk M, Neuhauser C. Continuous S-(+)-ketamine administration during elective coronary artery bypass graft surgery attenuates pro-inflammatory cytokine response during and after cardiopulmonary bypass. Br J Anaesth. 2011 Feb;106(2):172-9. doi: 10.1093/bja/aeq341. Epub 2010 Dec 7.
Results Reference
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Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery

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