Safety and Efficacy of Esketamine Combined With Dexmedetomidine for Sedation of Mechanically Ventilated Patients
- Conditions
- AnalgesiaMechanical VentilationDexmedetomidineKetamineIntensive Care Units
- Interventions
- Registration Number
- NCT05466708
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Mechanically ventilated with oral endotracheal intubation in the ICU;
- Patients aged >18 years and <70 years;
- Patients with expected mechanical ventilation time >24 hours.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esketamine combined with dexmedetomidine Esketamine combined with dexmedetomidine 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. Dexmedetomidine Dexmedetomidine 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
- Primary Outcome Measures
Name Time Method Duration of mechanical ventilation Usually within 14 days Duration of mechanical ventilation after endotracheal intubation
- Secondary Outcome Measures
Name Time Method Adverse reactions Within 28 days Adverse reactions that patients experience with the medication, such as hypertension, hypotension, rapid heart rate, slow heart rate
Dose of Propofol Within 14 days Total dose of rescue propofol
Duration of ICU stay Usually within 28 days Length of stay in ICU
Time to extubation Usually within 14 days Daily offline screening, SBT test if eligible, and extubation if SBT is successful
28-day mortality rate Within 28 days Mortality of patients within 28 days from the time of tracheal intubation
Recovery time Within 14 days From the stop of sedatives to awakening
Occurrence of delirium Within 14 days The proportion of participants who have at least one positive CAM-ICU
Trial Locations
- Locations (1)
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China