Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients
Study Details
Study Description
Brief Summary
Sedation and analgesia in patients with sepsis and hemodynamic instability may be challenging in the ICU. Opioids and propofol can further exacerbate tissue infusion in septic shock by reducing cardiac contractility, increasing vasodilation, and reducing respiratory drive. Ketamine is an NMDA receptor antagonist, which has no effect on respiratory drive and has diastolic airway smooth muscle and anti-inflammatory properties. Esketamine is a dextrorotatory cleavage twice as potent and reduces the incidence of dose-dependent side effects of ketamine. Although it has been successfully used in burn patients undergoing multiple operations and anesthesia-related maintenance analgesia, it has not been reported in ICU septic shock patients undergoing mechanical ventilation. The purpose of this study was to explore the use of esketamine in mechanically ventilated ICU septic shock patients in a single-center randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
In order to further clarify whether Esketamine can be used as a conventional continuous intravenous infusion drug in the ICU, further RCT is required. Therefore, this project assumes that low-dose Esketamine has a clear analgesic and sedative effect, and has advantages such as less adverse reactions in hemodynamics, respiratory inhibition, and gastrointestinal peristalsis. It is proposed to complete the following work: on the standard analgesia and sedation scheme (remifentanil+propofol), evaluate the feasibility, effectiveness and safety of the auxiliary analgesia scheme added with esketamine for septic shock patients with mechanical ventilation by whether to load small dose of esketamine for infusion, so as to provide basis for follow-up individualized diagnosis and treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Remifentanil + propofol + esketamine esketamine (2ml; 50mg), Remifentanil Hydrochloride for Injection (1mg;), propofol injection (50ml; 0.5g; )； The frequency of use is determined by responsible clinicians.All analgesic and sedative drugs used are adjusted according to the actual situation of the patient. |
Drug: Esketamine
Load dose of 0.25 mg/kg, and the fixed infusion rate of 0.15 mg/kg/h.The load dose will be injected intravenously within 1-2 minutes.
Preparation: 50ml of saline + 2ml of eskeamine.
Other Names:
Drug: Remifentanil + propofol
Remifentanil + propofol
|
| Placebo Comparator: remifentanil + propofol + saline Remifentanil Hydrochloride for Injection (1mg;), propofol injection (50ml; 0.5g; )； The amount of saline used is equivalent to the amount of esketamine.All analgesic and sedative drugs used are adjusted according to the actual situation of the |
Drug: Saline
As a placebo,normal saline at the same dose as esketamine.Saline is also administered intravenously.
Other Names:
Drug: Remifentanil + propofol
Remifentanil + propofol
|
Outcome Measures
Primary Outcome Measures
- Doses of remifentanil and norepinephrine during mechanical ventilation (total dose/duration of use). [During mechanical ventilation procedure (From randomization to the seventh day of infusion or ventilator withdrawal, whichever occurs first）]
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication.
Secondary Outcome Measures
- Duration of mechanical ventilation. [From endotracheal intubation to withdrawal from mechanical ventilation, or until 28 days after discharge, death, or randomization in the ICU, whichever occurs]
Responsible researchers obtain information by viewing electronic medical records.
- No ventilator days. [Days to 28]
Responsible researchers obtain information by viewing electronic medical records.
- Propofol dosage (total dose/duration of use) during mechanical ventilation. [During mechanical ventilation procedure (From randomization to the seventh day of infusion or ventilator withdrawal, whichever occurs first）]
Responsible researchers consult the patient's medical record after completing treatment to obtain the dosage and duration of medication.
- The proportion of patients meeting the RASS sedation and CPOT pain goals during mechanical ventilation. [up to 28 days]
Professionally trained researchers perform RASS and COPT scores on patients at specific time points.
- The incidence of delirium, i.e. the positive rate of CAM-ICU. [up to 28 days]
The occurrence of delirium in patients will be recorded by clinicians or nurses on medical records, and researchers will summarize the occurrence of delirium (such as the time of occurrence, duration, treatment measures, etc.)Patients will be evaluated using CAM-ICU by clinicians or nurses.
- Incidence of adverse events. [up to 28 days]
The occurrence of adverse events during the hospital period will be recorded in the medical record by the clinician or nurse, and the researcher will obtain the occurrence of adverse events (event type, time, treatment, results, etc.) through the medical record.
- length of ICU stay. [up to 28 days]
Researchers obtain it through the hospital electronic system.
- The mortality rate [up to 28 days]
Researchers obtain it through the hospital electronic system.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18;
-
A patient diagnosed with septic shock;
-
It needs to be treated with analgesics, sedatives, and vasopressors for a period of not less than 48 hours;
-
Mechanical ventilation by the ventilator is needed;
-
Obtain the informed consent of the human subjects or their legal representatives;
Exclusion Criteria:
-
Pregnant patient
-
The patient had acute coronary syndrome, NYHA grade IV, or refractory heart failure;
-
Any other condition that may seriously interfere with the collection of research data, such as loss of hearing or vision;
-
any allergic reaction to any of the research drugs;
-
The clinician determines that a patient who is unlikely to be separated from mechanical ventilation, such as a disease/injury that primarily affects the neuromuscular function of the respirator and an apparently irreversible disease requiring long-term ventilation support (such as high spinal cord injury);
-
The researcher judged that it was not suitable to participate in the study;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern medical university Nanfang hospital | Guangzhou | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NFEC-2022-394