Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT05466708

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-05-07

100

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mechanically ventilated with oral endotracheal intubation in the ICU
  • Aged over 18 years and under 70 years
  • Expected mechanical ventilation time greater than 24 hours
Not Eligible

You will not qualify if you...

  • Known or suspected allergy to esketamine, dexmedetomidine, remifentanil, or propofol
  • Pregnancy or lactation
  • Obesity with Body Mass Index over 35 kg/m2
  • Extreme hemodynamic or respiratory instability due to severe burn or trauma (Injury Severity Score 65)
  • Heavy drinking as defined by WHO (at least 60g pure alcohol daily for men, 40g for women)
  • Terminally ill patients near death, such as with metastatic tumors or refractory shock
  • Long-term use of sedatives, opioid analgesics, or antianxiety drugs
  • Severe central nervous system diseases such as stroke, status epilepsy, or coma
  • Acute or chronic severe liver disease (Child-Pugh class C or liver transplant history)
  • Acute or chronic kidney failure requiring dialysis
  • Refusal to provide informed consent
  • Mechanically ventilated for more than 24 hours before enrollment (excluding time in operation room)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 225500

Actively Recruiting

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Research Team

Z

Zuo Xiangrong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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