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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
Sponsor:
Information provided by (Responsible Party):
Jianbo Yu, Tianjin Nankai Hospital

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:
  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

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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


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%.




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



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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

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
Publications:
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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