- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05466708
Efficacy and Safety of Esketamine Combined With Dexmedetomidine for Sedation Iof Mechanically Ventilated Patients
Efficacy and Safety of Esketamine Combined With Dexmedetomidine for Sedation Iof Mechanically Ventilated Patients in the ICU: a Prospective, Randomized, Single-center Study
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Zuo Xiangrong
- Phone Number: +86 13913979197
- Email: zuoxiangrong@njmu.edu.cn
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 225500
- The First Affiliated Hospital with Nanjing Medical University
-
Contact:
- Zuo Xiangrong
- Phone Number: +86 13913979197
- Email: zuoxiangrong@njmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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
|
Dexmedetomidine, injection, 0.2mg/ bottle, source: Hospital Pharmacy, manufacturer: Jiangsu Hengrui Pharmaceutical Co., LTD., expiration date: 18 months, storage condition: airtight shading, room temperature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of mechanical ventilation
Time Frame: Usually within 14 days
|
Duration of mechanical ventilation after endotracheal intubation
|
Usually within 14 days
|
Time to extubation
Time Frame: Usually within 14 days
|
Daily offline screening, SBT test if eligible, and extubation if SBT is successful
|
Usually within 14 days
|
Duration of ICU stay
Time Frame: Usually within 28 days
|
Length of stay in ICU
|
Usually within 28 days
|
28-day mortality rate
Time Frame: 28 days
|
Mortality of patients within 28 days from the time of tracheal intubation
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse reactions
Time Frame: 28 days
|
Adverse reactions that patients experience with the medication, such as hypertension, hypotension, rapid heart rate, slow heart rate
|
28 days
|
Collaborators and Investigators
Investigators
- Study Chair: Zuo Xiangrong, Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Psychotropic Drugs
- Antidepressive Agents
- Hypnotics and Sedatives
- Ketamine
- Dexmedetomidine
- Esketamine
Other Study ID Numbers
- 2021120884Esketamine
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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