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
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
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.
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
NCT ID
NCT05551910
First Posted
September 8, 2022
Last Updated
September 22, 2022
Sponsor
The First Hospital of Jilin University
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
Learn more about this trial
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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