RecruitingPhase 4NCT05466708

Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients

Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients in the ICU: a Prospective, Randomized, Single-center Study


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

100 participants

Start Date

Aug 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, randomized controlled study was conducted to compare the effects of esketamine combined with dexmedetomidine in the sedation and analgesia treatment of mechanically ventilated patients in the ICU on the time to awaken, time to extubation, time to mechanical ventilation, time in the ICU, and on delirium.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether combining two sedation medications — esketamine and dexmedetomidine — is safe and effective for patients on breathing machines in the ICU. The goal is to find a sedation approach that is better tolerated and leads to better recovery. You may be eligible if... - You are between 18 and 70 years old - You are on a mechanical ventilator (breathing machine) in an ICU with a tube through your mouth - You are expected to need the ventilator for more than 24 hours You may NOT be eligible if... - You have a known allergy to esketamine, dexmedetomidine, remifentanil, or propofol - You are pregnant or breastfeeding - Your BMI is over 35 kg/m² - You have severe burns or trauma (Injury Severity Score ≥25) - You drink heavily (60g+ pure alcohol/day for men, 40g+ for women) - You have terminal illness (e.g., widespread metastatic cancer) - You take sedatives, opioids, or anti-anxiety drugs long-term - You have severe neurological conditions (stroke, epilepsy, coma) - You have severe liver or kidney disease - You have been on the ventilator for more than 24 hours before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsketamine combined with dexmedetomidine

Esketamine, injection, 50mg/ bottle, source: hospital pharmacy, production unit: Jiangsu Hengrui Pharmaceutical Co., LTD., validity: 2 years, storage condition: airtight shading, room temperature. Dexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature.

DRUGDexmedetomidine

Dexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT05466708


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