Clinical trial NCT05551910: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation
Keywords: septic shock; invasive mechanical ventilation;ICU
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Norepinephrine dosage in two groups
timeFrame: 2 years
Secondary outcomes:
measure: Time of mechanical ventilation
timeFrame: During hospitalization, an average of 4 days
measure: The incidence of intestinal dysfunction
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
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