NCT05839366

Adjunctive Esketamine for Analgesia in Mechanically Ventilated Septic Shock Patients

Adjunctive Esketamine for Analgesia in Mechanically Ventilated ICU Septic Shock Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Septic Shock
• Mechanical Ventilation Complication

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-31
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-05-03
• Last updated: 2023-11-22

Locations

1 site across 1 country: China