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Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation

Primary Purpose

Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Esketamine
Remifentanil
propofol
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation focused on measuring septic shock; invasive mechanical ventilation;ICU

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults (aged 18-75 years)
  2. Septic shock patients with invasive mechanical ventilation
  3. Use norepinephrine (the only vasoactive drug) to maintain the target map ≥ 65 mmHg
  4. BMI 18.5-23.9kg/m2

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Patients allergic to planned drugs;
  3. Hypertension patients with poor control;
  4. Patients with mental illness, chronic pain, seizures, elevated intracranial pressure, severe ischemic heart disease, and bronchial asthma;
  5. Patients included in other trial items;
  6. Other reasons that the researcher considers unsuitable to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Analgesia and sedation with esmketamine combined with propofol

    Remifentanil combined with propofol for analgesia and sedation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Norepinephrine dosage in two groups
    mg/kg

    Secondary Outcome Measures

    Time of mechanical ventilation
    day
    The incidence of intestinal dysfunction
    percent

    Full Information

    First Posted
    September 8, 2022
    Last Updated
    September 22, 2022
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05551910
    Brief Title
    Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation
    Official Title
    Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    March 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Septic shock patients with invasive mechanical ventilation who were randomly enrolled in ICU were divided into esketamine group (test group) and remifentanil group (control group) according to the ratio of 1:1. The dose of vasopressor, the time of mechanical ventilation, the incidence of intestinal dysfunction and the dose of propofol were compared between the two groups. Through statistical analysis, it was determined whether esketamine combined with propofol could improve the prognosis of septic shock patients with invasive mechanical ventilation and reduce the adverse reactions of analgesic and sedative drugs compared with remifentanil combined with propofol.
    Detailed Description
    The purpose of this study is to determine whether esketamine combined with propofol can improve the prognosis and reduce the adverse effects of analgesic and sedative drugs in septic shock patients undergoing invasive mechanical ventilation compared with remifentanil combined with propofol. Study methods: septic shock patients with invasive mechanical ventilation in ICU were randomly divided into esketamine group (test group) and remifentanil group (control group) according to the ratio of 1:1. 120 patients are expected to be enrolled. The dose of vasopressor, the time of mechanical ventilation, the incidence of intestinal dysfunction and the dose of propofol were compared between the two groups. Through statistical analysis, it was determined whether esketamine combined with propofol could improve the prognosis of septic shock patients with invasive mechanical ventilation and reduce the adverse reactions of analgesic and sedative drugs compared with remifentanil combined with propofol. From January 1, 2023 to January 1, 2024, the clinical study of the patients (60 cases) enrolled in the first phase was completed as expected in the study protocol. Stage objective: to count the relevant detection indicators of the two groups of patients, analyze and compare whether there is a difference between the primary endpoint and the secondary observation endpoint, and write a research paper and a mid-term summary. From January 1, 2024 to January 1, 2025, the clinical study of patients (60 cases) enrolled in the second phase was completed according to the research protocol. Stage objective: to count the relevant detection indicators of the two groups of patients, analyze and compare whether there is a difference between the primary endpoint and the secondary observation endpoint, and write a research paper and a conclusion report. Publication form of research results: 1-2 academic papers published in domestic or international journals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation
    Keywords
    septic shock; invasive mechanical ventilation;ICU

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    RCT
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Analgesia and sedation with esmketamine combined with propofol
    Arm Type
    Experimental
    Arm Title
    Remifentanil combined with propofol for analgesia and sedation
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine
    Intervention Description
    The patients in the test group were given esmketamine (50mg / 2ml * branch, Jiangsu Hengrui Pharmaceutical Co., Ltd.) 0.15-0.5mg/kg H was pumped intravenously. Two minutes after the administration, the pain was scored with the cpot pain observation scale. The target cpot was < 3 points. The dose of esketamine was adjusted according to the cpot score.
    Intervention Type
    Drug
    Intervention Name(s)
    Remifentanil
    Intervention Description
    Patients in the control group were given remifentanil (1mg / branch, Yichang humanwell Pharmaceutical Co., Ltd.) 0.05-2ug/kg Minutes after administration, the analgesic score was measured with cpot pain observation scale. The target cpot was less than 3 points, and the dose of remifentanil was adjusted according to the cpot score.
    Intervention Type
    Drug
    Intervention Name(s)
    propofol
    Intervention Description
    propofol
    Primary Outcome Measure Information:
    Title
    Norepinephrine dosage in two groups
    Description
    mg/kg
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Time of mechanical ventilation
    Description
    day
    Time Frame
    During hospitalization, an average of 4 days
    Title
    The incidence of intestinal dysfunction
    Description
    percent
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults (aged 18-75 years) Septic shock patients with invasive mechanical ventilation Use norepinephrine (the only vasoactive drug) to maintain the target map ≥ 65 mmHg BMI 18.5-23.9kg/m2 Exclusion Criteria: Pregnant or lactating women; Patients allergic to planned drugs; Hypertension patients with poor control; Patients with mental illness, chronic pain, seizures, elevated intracranial pressure, severe ischemic heart disease, and bronchial asthma; Patients included in other trial items; Other reasons that the researcher considers unsuitable to participate in this study.

    12. IPD Sharing Statement

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    Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation

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