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

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ClinicalTrials.gov Identifier: NCT04873479

Recruitment Status : Recruiting

First Posted : May 5, 2021

Last Update Posted : August 31, 2021

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Sponsor:

Information provided by (Responsible Party):

Jianbo Yu, Tianjin Nankai Hospital

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.

Condition or disease	Intervention/treatment	Phase
Sepsis Acute Lung Injury	Drug: S-ketamine Other: saline	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery:a Single Center, Randomized, Controlled Trial
Actual Study Start Date :	May 10, 2021
Estimated Primary Completion Date :	December 31, 2022
Estimated Study Completion Date :	October 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine Esketamine

Genetic and Rare Diseases Information Center resources: Acute Respiratory Distress Syndrome Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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%.	Other: 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%.

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873479

Contacts

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Contact: Jianbo Yu MD PhD	86-22-27435873	yujianbo11@126.com

Locations

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China, Tianjin
Tianjin Nankai Hospital	Recruiting
Tianjin, Tianjin, China, 300000
Contact: Yu Jianbo, Professor （022）27435008 ext （022）27435027 yujianbo11@126.com

Sponsors and Collaborators

Tianjin Nankai Hospital

Investigators

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Study Chair:	Jianbo Yu MD PhD	Tianjin Nankai Hospital

More Information

Publications:

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.

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.

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.

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.

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Responsible Party:	Jianbo Yu, Department of anesthesiology , Director, Chief physician, Tianjin Nankai Hospital
ClinicalTrials.gov Identifier:	NCT04873479
Other Study ID Numbers:	ASLAT20210430
First Posted:	May 5, 2021 Key Record Dates
Last Update Posted:	August 31, 2021
Last Verified:	August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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

Keywords provided by Jianbo Yu, Tianjin Nankai Hospital:


sepsis acute lung injury S-ketamine Inflammation

Additional relevant MeSH terms:

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Lung Injury Acute Lung Injury Lung Diseases Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries Ketamine Esketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents Psychotropic Drugs

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