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

NCT05466708 | Recruiting Phase 4

• 1 other identifier: 2021120884Esketamine
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dexmedetomidine; Ketamine; Analgesia; Intensive Care Units; Mechanical Ventilation

Keywords

Dexmedetomidine; Esketamine; Analgesia; Sedation; Intensive Care Units; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  Duration of mechanical ventilation after endotracheal intubation

  Usually within 14 days

Secondary Outcomes (7)

• Time to extubation

  Usually within 14 days

• Duration of ICU stay

  Usually within 28 days

• 28-day mortality rate

  Within 28 days

• Recovery time

  Within 14 days

• Dose of Propofol

  Within 14 days

Study Arms (2)

Esketamine combined with dexmedetomidine

EXPERIMENTAL

Esketamine will be administered at 1mg/kg, IVP, then intravenously pumped at 0.25-1.5mg/kg/h in combination with dexmedetomidine 1μg/kg for 20 min, followed by continuous intravenously pumped at 0.2-0.7mg/kg/h, maintaining a RASS score of -2-0.

Drug: Esketamine combined with dexmedetomidine

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine will be administered at 1μg/kg for 20 min, followed by continuous intravenous pumping at 0.2-0.7mg/kg/h to maintain a RASS score of -2-0

Drug: Dexmedetomidine

Interventions

Esketamine combined with dexmedetomidine DRUG

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.

Also known as: S-ketamine combined with dexmedetomidine

Esketamine combined with dexmedetomidine

Dexmedetomidine DRUG

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

Also known as: Dexmedetomidine Hydrochloride Injection

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated with oral endotracheal intubation in the ICU;
• Patients aged \>18 years and \<70 years;
• Patients with expected mechanical ventilation time \>24 hours.

You may not qualify if:

• Known or suspected allergy to esketamine, dexmedetomidine, remifentanil, or propofol;
• Pregnancy or lactation periods;
• Obesity defined as Body Mass Index \>35kg/m2;
• Extreme hemodynamic or respiratory instability due to severe burn or trauma (defined as Injury Severity Score ≥25);
• Heavy drinking defined by WHO as drinking at least 60g of pure alcohol every day for men and at least 40g for women;
• Terminally ill patients near death, such as patients with extensively metastatic tumor or refractory shock;
• Long-term exposure to sedatives, opioid analgesics or antianxiety drugs;
• Severe central nervous system disease such as cerebrovascular accidents, status epilepsy, or coma;
• Acute or chronic severe liver disease (Child-Pugh class C or history of liver transplant);
• Acute or chronic renal insufficiency needing dialysis;
• Patients or authorized surrogates refuse to provide informed consents;
• Mechanically ventilated for more than 24 hours prior to enrollment (not including the time on ventilators in the operation room).

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 225500, China

RECRUITING

Related Publications (1)

• Zhang W, You J, Hu J, Chen X, Wang H, Li N, Wei C, Tang W, Zuo X. Effect of esketamine combined with dexmedetomidine on delirium in sedation for mechanically ventilated ICU patients: protocol for a nested substudy within a randomized controlled trial. Trials. 2024 Jul 2;25(1):431. doi: 10.1186/s13063-024-08287-3.

  PMID: 38956664 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zuo Xiangrong

  Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Zuo Xiangrong

CONTACT

+86 13913979197; zuoxiangrong@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 20, 2022
• Study Start: August 11, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CN (1)