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

Sepsis Clinical Trial

Official title:

Effect of S-ketamine Anesthetic on Inflammatory Response in Septic Patients Undergoing Abdominal Surgery:a Single Center, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04873479
• Other study ID #: ASLAT20210430
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: August 2021
• Source: Tianjin Nankai Hospital
• Contact: Jianbo Yu MD PhD
• Phone: 86-22-27435873
• Email: yujianbo11[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Sepsis

Intervention

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%.

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%.

Locations

Country	Name	City	State
China	Tianjin Nankai Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View 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. Review. Erratum in: Pharmacol Rev. 2018 Oct;70(4):879. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of postoperative pulmonary complications	such as pneumonia,atelectasis ,pleural effusion,respiratory insufficiency,etc	an average of 1 week
Secondary	Inflammatory indicators: leukocyte, CRP, PCT levels	leukocyte, CRP, PCT levels	an average of 1 day
Secondary	Inflammatory factors	IL-6, TNF-a, CC-16,activity of HO-1	an average of 1 day
Secondary	imaging diagnosis	chest X-ray,ultrasound	an average of 1 week
Secondary	therapies for respiratory insufficiency	nasal cannula,face mask,postoperative noninvasive ventilation, re-intubation with postoperative mechanical ventilation	an average of 1 week
Secondary	Incidence of postoperative adverse reactions	such as restlessness, delirium, salivation, nausea, vomiting, respiratory depression, dizziness, etc	an average of 1 week
Secondary	Length of stay in ICU	The time from the patient's surgery to leave the ICU	an average of 1 month
Secondary	Opioid consumption	consumption of sufentanil and remifentanil	an average of 1 day