Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients

PHASE3RecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

May 31, 2023

Primary Completion Date

October 31, 2024

Study Completion Date

October 31, 2024

Conditions
Septic ShockMechanical Ventilation Complication
Interventions
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.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."

DRUG

Saline

As a placebo,normal saline at the same dose as esketamine.Saline is also administered intravenously.

DRUG

Remifentanil + propofol

Remifentanil + propofol

PROCEDURE

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."

Trial Locations (1)

510515

RECRUITING

Southern medical university Nanfang hospital, Guangzhou

All Listed Sponsors
lead

Nanfang Hospital, Southern Medical University

OTHER