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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation
• Intervention / Treatment: Drug: Esketamine; Drug: propofol; Drug: Remifentanil

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Analgesia and sedation with esmketamine combined with propofol	Drug: Esketamine; 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.; Drug: propofol; propofol
Other: Remifentanil combined with propofol for analgesia and sedation	Drug: propofol; propofol; Drug: Remifentanil; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Norepinephrine dosage in two groups	mg/kg	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of mechanical ventilation	day	During hospitalization, an average of 4 days
The incidence of intestinal dysfunction	percent	2 years

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: septic shock; invasive mechanical ventilation;ICU
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Remifentanil; Propofol; Esketamine
• Other Study ID Numbers: Yuting Li

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No