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

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ClinicalTrials.gov Identifier: NCT05466708
Recruitment Status : Not yet recruiting
First Posted : July 20, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE July 12, 2022
First Posted Date  ICMJE July 20, 2022
Last Update Posted Date July 20, 2022
Estimated Study Start Date  ICMJE August 2022
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2022)
  • Duration of mechanical ventilation [ Time Frame: Usually within 14 days ]
    Duration of mechanical ventilation after endotracheal intubation
  • Time to extubation [ Time Frame: Usually within 14 days ]
    Daily offline screening, SBT test if eligible, and extubation if SBT is successful
  • Duration of ICU stay [ Time Frame: Usually within 28 days ]
    Length of stay in ICU
  • 28-day mortality rate [ Time Frame: 28 days ]
    Mortality of patients within 28 days from the time of tracheal intubation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2022)
Adverse reactions [ Time Frame: 28 days ]
Adverse reactions that patients experience with the medication, such as hypertension, hypotension, rapid heart rate, slow heart rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Esketamine Combined With Dexmedetomidine for Sedation Iof Mechanically Ventilated Patients
Official Title  ICMJE Efficacy and Safety of Esketamine Combined With Dexmedetomidine for Sedation Iof Mechanically Ventilated Patients in the ICU: a Prospective, Randomized, Single-center Study
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.
Detailed Description

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with rapid onset of action, easy to wake up, no accumulation in the body, little inhibition of respiration, sedative, hypnotic and anxiolytic effects, and also has a certain analgesic effect.Clinical studies have shown that the use of dexmedetomidine for sedation in ICU patients is beneficial in reducing the duration of mechanical ventilation and the incidence of delirium is low, but the sedative effect of dexmedetomidine is relatively weak, and has the side effects of slowing down heart rate and lowering blood pressure, so its clinical application is limited.Esketamine is an isomer of ketamine, its effect is stronger than ketamine, and glutamate N-methyl D-aspartate (NMDA) receptor binding, play a sedative, hypnotic, analgesic effect, rapid onset, strong effect, and small respiratory inhibition, bronchodilator effect, the disadvantage is that there is a vasoconstrictor effect can cause increased blood pressure, increased heart rate.

The combination of esketamine and dexmedetomidine can provide effective sedation and analgesia with the advantages of maintaining hemodynamic stability, maintaining stable spontaneous breathing and reducing psychiatric symptoms, and has been successfully used in clinical operations such as endoscopy, pediatric anesthesia and outpatient tooth extraction.

The effectiveness and safety of esketamine in combination with dexmedetomidine for the sedation of mechanically ventilated patients in the ICU has not been evaluated. In this study, a prospective, randomized, controlled, single-center study was conducted to evaluate the efficacy and safety of esketamine in combination with dexmedetomidine for the sedation of mechanically ventilated patients in the ICU.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dexmedetomidine
  • Ketamine
  • Analgesia
  • Intensive Care Units
  • Mechanical Ventilation
Intervention  ICMJE
  • Drug: Esketamine combined with dexmedetomidine

    Asic ketamine, 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.

    Other Name: S-ketamine combined with dexmedetomidine
  • Drug: Dexmedetomidine
    Dexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature.
Study Arms  ICMJE
  • Experimental: Esketamine combined with dexmedetomidine
    Esticketamine was administered at 1mg/kg, IVP, then intravenously pumped at 0.25-1.5mg/ kg (kg×h) in combination with dexmedetomidine 1.0μg/kg for 20 min, followed by continuous intravenously pumped at 0.2-0.7mg/ kg (kg×h), maintaining a RASS score of -2-0.
    Intervention: Drug: Esketamine combined with dexmedetomidine
  • Active Comparator: Dexmedetomidine
    Dexmedetomidine was administered at 1.0μg/kg for 20 min, followed by continuous intravenous pumping at 0.2-0.7mg/ kg×h to maintain a RASS score of -2-0
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2022)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2023
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients admitted to ICU for tracheal intubation and mechanical ventilation; Patients aged >18 years and <65 years; Patients with expected mechanical ventilation time >24 hours.

Exclusion Criteria:

Patients with known or suspected hypersensitivity to esketamine, propofol, dexmedetomidine, or remifentanil; Pregnancy, hyperlipidemia, excessive obesity, end-stage patients; Patients with burns or severe trauma; alcoholics; Patients on long-term anti-anxiety medication or sleeping pills; Patients with severe central nervous system diseases; Patients with acute and chronic liver insufficiency; Patients with acute and chronic renal insufficiency requiring dialysis; Patients who do not wish to sign the informed consent form.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zuo Xiangrong +86 13913979197 zuoxiangrong@njmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05466708
Other Study ID Numbers  ICMJE 2021120884Esketamine
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The First Affiliated Hospital with Nanjing Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zuo Xiangrong Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP