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

Not Applicable

Not yet recruiting

• Conditions: Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation
• Interventions: Drug: Esketamine; Drug: Remifentanil; Drug: propofol

• Registration Number: NCT05551910
• Lead Sponsor: The First Hospital of Jilin University

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-23
• Last Update Posted: 2022-09-23
• Study Start: 2023-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Analgesia and sedation with esmketamine combined with propofol	propofol	-
Analgesia and sedation with esmketamine combined with propofol	Esketamine	-
Remifentanil combined with propofol for analgesia and sedation	propofol	-
Remifentanil combined with propofol for analgesia and sedation	Remifentanil	-

Primary Outcome Measures

Name	Time	Method
Norepinephrine dosage in two groups	2 years	mg/kg

Secondary Outcome Measures

Name	Time	Method
The incidence of intestinal dysfunction	2 years	percent
Time of mechanical ventilation	During hospitalization, an average of 4 days	day