Patients With Septic Shock Admitted to the ICU on Invasive Mechanical VentilationNCT05551910
Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation
A study testing Esketamine, Remifentanil and propofol in people with Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation, run by The First Hospital of Jilin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation
- What is being tested?
- Esketamine, Remifentanil and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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.
- Being tested
- Esketamine, Remifentanil, propofol
- Keywords
- septic shock; invasive mechanical ventilation;ICU
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
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.
RemifentanilDrug
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.
propofolDrug
propofol
| Study group | Role | What they receive |
|---|---|---|
| Analgesia and sedation with esmketamine combined with propofol | Experimental | Not described Receives: Drug: Esketamine; Drug: propofol |
| Remifentanil combined with propofol for analgesia and sedation | Other | Not described Receives: Drug: Remifentanil; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Norepinephrine dosage in two groups
mg/kg
Measured: 2 years
Secondary outcomes (2)
Time of mechanical ventilation
day
Measured: During hospitalization, an average of 4 days
The incidence of intestinal dysfunction
percent
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Septic Shock Admitted to the ICU on Invasive Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuting Li, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551910
- Sponsor's protocol ID
- Yuting Li
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Li H, Zhang F, Chen Y, Zhang D. Effects of Esketamine Versus Remifentanil on Hemodynamics and Prognosis in Patients with Septic Shock Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 May 21;19:4139-4149. doi: 10.2147/DDDT.S520252. eCollection 2025.
PubMed 40416798
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05551910
- Acronym / sponsor ID
- Yuting Li
- Keywords
- septic shock; invasive mechanical ventilation;ICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Analgesia and sedation with esmketamine combined with propofol | Experimental | Drug: Esketamine, Drug: propofol |
| Remifentanil combined with propofol for analgesia and sedation | Other | Drug: Remifentanil, Drug: propofol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineThe 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 | Analgesia and sedation with esmketamine combined with propofol |
| RemifentanilPatients 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. | Drug | Remifentanil combined with propofol for analgesia and sedation |
| propofolpropofol | Drug | Analgesia and sedation with esmketamine combined with propofol, Remifentanil combined with propofol for analgesia and sedation |
Primary outcome
Norepinephrine dosage in two groups
Time frame: 2 years
mg/kg
2 secondary outcomes
Time of mechanical ventilation
Time frame: During hospitalization, an average of 4 days
The incidence of intestinal dysfunction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 40416798Li Y, Li H, Zhang F, Chen Y, Zhang D. Effects of Esketamine Versus Remifentanil on Hemodynamics and Prognosis in Patients with Septic Shock Receiving Invasive Mechanical Ventilation: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 May 21;19:4139-4149. doi: 10.2147/DDDT.S520252. eCollection 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine, Remifentanil and propofol in people with Patients With Septic Shock Admitted to the ICU on Invasive Mechanical Ventilation, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Norepinephrine dosage in two groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.