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History of Changes for Study: NCT04873479
Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery
Latest version (submitted August 30, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 30, 2021 None (earliest Version on record)
2 August 30, 2021 Recruitment Status, Study Status and Contacts/Locations
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Study NCT04873479
Submitted Date:  April 30, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: ASLAT20210430
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2021
Overall Status: Not yet recruiting
Study Start: May 15, 2021
Primary Completion: December 31, 2022 [Anticipated]
Study Completion: October 30, 2023 [Anticipated]
First Submitted: April 30, 2021
First Submitted that
Met QC Criteria:
April 30, 2021
First Posted: May 5, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 30, 2021
Last Update Posted: May 5, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Tianjin Nankai Hospital
Responsible Party: Principal Investigator
Investigator: Jianbo Yu
Official Title: Department of anesthesiology , Director, Chief physician
Affiliation: Tianjin Nankai Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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:
  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: Randomized,double-blind, Controlled Trial
  4. 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
  5. Sample size: Enroll 50 patients (25 patients in each group)
  6. 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.

  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 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
  9. The estimated duration of the study#1-2years
Open or close this module Conditions
Conditions: Sepsis
Acute Lung Injury
Keywords: sepsis
acute lung injury
S-ketamine
Inflammation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: test group
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%.
Drug: S-ketamine
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%.
control group
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%.
saline
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%.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. the incidence of postoperative pulmonary complications
[ Time Frame: an average of 1 week ]

such as pneumonia,atelectasis ,pleural effusion,respiratory insufficiency,etc
Secondary Outcome Measures:
1. Inflammatory indicators: leukocyte, CRP, PCT levels
[ Time Frame: an average of 1 day ]

leukocyte, CRP, PCT levels
2. Inflammatory factors
[ Time Frame: an average of 1 day ]

IL-6, TNF-α, CC-16,activity of HO-1
3. imaging diagnosis
[ Time Frame: an average of 1 week ]

chest X-ray,ultrasound
4. therapies for respiratory insufficiency
[ Time Frame: an average of 1 week ]

nasal cannula,face mask,postoperative noninvasive ventilation, re-intubation with postoperative mechanical ventilation
5. Incidence of postoperative adverse reactions
[ Time Frame: an average of 1 week ]

such as restlessness, delirium, salivation, nausea, vomiting, respiratory depression, dizziness, etc
6. Length of stay in ICU
[ Time Frame: an average of 1 month ]

The time from the patient's surgery to leave the ICU
7. Opioid consumption
[ Time Frame: an average of 1 day ]

consumption of sufentanil and remifentanil
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Jianbo Yu MD PhD
Telephone: 86-22-27435873
Email: yujianbo11@126.com
Study Officials: Jianbo Yu MD PhD
Study Chair
Tianjin Nankai Hospital
Locations: China, Tianjin
Tianjin Nankai Hospital
Tianjin, Tianjin, China, 300000
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: Trimmel H, Helbok R, Staudinger T, Jaksch W, Messerer B, Schöchl 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. Review. Erratum in: Wien Klin Wochenschr. 2018 Sep;130(17-18):557. PubMed 29322377
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. PubMed 27829093
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. Review. Erratum in: Pharmacol Rev. 2018 Oct;70(4):879. PubMed 29945898
Welters ID, Feurer MK, Preiss V, Müller M, Scholz S, Kwapisz M, Mogk M, Neuhäuser 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. PubMed 21138901
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