Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients
NCT ID: NCT05839366
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
124 participants
INTERVENTIONAL
2023-05-31
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.Maintain the infusion at a fixed rate of 0.15 mg/kg/h for 72 hours; after 72 hours, change to a fixed rate infusion of 0.06 mg/kg/h.
Preparation: 46ml of saline + 4ml of eskeamine.
Remifentanil + propofol
Remifentanil + propofol
Pain and Sedation Assessment
RASS Score:
After randomization success, a baseline Richmond Agitation-Sedation Scale (RASS) score is obtained before administering the investigational drug. Pain assessments are conducted every 1 hour within the first 6 hours after the initiation of the intravenous loading dose of the investigational drug, every 4 hours within the first 24 hours, and subsequently every 8 hours until the end of the study. In addition to the fixed time points mentioned above, researchers may conduct RASS scoring at any time based on the subject's actual condition (excessive or inadequate sedation). (No further RASS scoring is performed once the subject is fully awake.)
CPOT Score:
CPOT（Critical-Care Pain Observation Tool）Pain assessments are conducted concurrently with RASS scoring.
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
Saline
As a placebo,normal saline at the same dose as esketamine.Saline is also administered intravenously.
Remifentanil + propofol
Remifentanil + propofol
Pain and Sedation Assessment
RASS Score:
After randomization success, a baseline Richmond Agitation-Sedation Scale (RASS) score is obtained before administering the investigational drug. Pain assessments are conducted every 1 hour within the first 6 hours after the initiation of the intravenous loading dose of the investigational drug, every 4 hours within the first 24 hours, and subsequently every 8 hours until the end of the study. In addition to the fixed time points mentioned above, researchers may conduct RASS scoring at any time based on the subject's actual condition (excessive or inadequate sedation). (No further RASS scoring is performed once the subject is fully awake.)
CPOT Score:
CPOT（Critical-Care Pain Observation Tool）Pain assessments are conducted concurrently with RASS scoring.
Interventions
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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.Maintain the infusion at a fixed rate of 0.15 mg/kg/h for 72 hours; after 72 hours, change to a fixed rate infusion of 0.06 mg/kg/h.
Preparation: 46ml of saline + 4ml of eskeamine.
Saline
As a placebo,normal saline at the same dose as esketamine.Saline is also administered intravenously.
Remifentanil + propofol
Remifentanil + propofol
Pain and Sedation Assessment
RASS Score:
After randomization success, a baseline Richmond Agitation-Sedation Scale (RASS) score is obtained before administering the investigational drug. Pain assessments are conducted every 1 hour within the first 6 hours after the initiation of the intravenous loading dose of the investigational drug, every 4 hours within the first 24 hours, and subsequently every 8 hours until the end of the study. In addition to the fixed time points mentioned above, researchers may conduct RASS scoring at any time based on the subject's actual condition (excessive or inadequate sedation). (No further RASS scoring is performed once the subject is fully awake.)
CPOT Score:
CPOT（Critical-Care Pain Observation Tool）Pain assessments are conducted concurrently with RASS scoring.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Confirmed acute severe intracranial or spinal neurologic diseases caused by vascular, intracranial expansion, or injury;
* History of uncontrolled or malignant hypertension (sustained (\>3 hours) heart rate \>150 beats/min or systolic blood pressure \>180 mmHg); recent history of ketamine use；
* Hearing or vision loss, or any other conditions likely to severely interfere with the collection of research data;
* Long-term use of benzodiazepines or opioids;
* Known allergy to any investigational drug;
* Subject receiving sedative therapy not for tolerance to mechanical ventilation (e.g., seizures);
* Unlikely to require ongoing sedation during mechanical ventilation (e.g., Guillain-Barré syndrome);
* Patients deemed unlikely by the attending physician to be weaned from mechanical ventilation, such as those with diseases/injuries primarily affecting respiratory neuromuscular function and conditions requiring prolonged ventilatory support, which are clearly irreversible (e.g., high spinal cord injury);
* Open eye injury or other ophthalmic diseases;
* Concurrent participation in any other interventional study (any study assigning subjects to different treatment groups and/or conducting unconventional diagnostic or monitoring procedures).
18 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Southern medical university Nanfang hospital
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFEC-2022-394
Identifier Type: -
Identifier Source: org_study_id