NCT04873479

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started May 2021

Typical duration for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

April 30, 2021

Last Update Submit

August 30, 2021

Conditions

SepsisAcute Lung Injury

Keywords

sepsisacute lung injuryS-ketamineInflammation

Outcome Measures

Primary Outcomes (1)

  • the incidence of postoperative pulmonary complications

    such as pneumonia,atelectasis ,pleural effusion,respiratory insufficiency,etc

    an average of 1 week

Secondary Outcomes (7)

  • Inflammatory indicators: leukocyte, CRP, PCT levels

    an average of 1 day

  • Inflammatory factors

    an average of 1 day

  • imaging diagnosis

    an average of 1 week

  • therapies for respiratory insufficiency

    an average of 1 week

  • Incidence of postoperative adverse reactions

    an average of 1 week

  • +2 more secondary outcomes

Study Arms (2)

test group

EXPERIMENTAL

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

control group

OTHER

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

Interventions

S-ketamineDRUG

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%.

test group
salineOTHER

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%.

control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29322377BACKGROUND

  • 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.

    PMID: 27829093BACKGROUND

  • 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.

    PMID: 29945898BACKGROUND

  • 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.

    PMID: 21138901BACKGROUND

MeSH Terms

Conditions

SepsisAcute Lung InjuryInflammation

Interventions

EsketamineSodium Chloride

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and SymptomsLung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jianbo Yu MD PhD

    Tianjin Nankai Hospital

    STUDY CHAIR

Central Study Contacts

Jianbo Yu MD PhD

CONTACT

86-22-27435873yujianbo11@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiology , Director, Chief physician

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 5, 2021

Study Start

May 10, 2021

Primary Completion

December 31, 2022

Study Completion

October 30, 2023

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)