Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients

Fuling Central Hospital of Chongqing City

Status and phase: Unknown; Phase 4

Conditions: Safety of Dexmedetomidine Sedation

Treatments: Drug: Midazolam; Drug: Dexmedetomidine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02225210

Shu 2014

Details and patient eligibility

About

This study was designed to observe the effects of dexmedetomidine on delirium and haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of dexmedetomidine.

Enrollment: 80 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Intensive care unit patients who need mechanical ventilation
• Anticipate duration of mechanical ventilation longer than 24 hours,and shorter than 96 hours prior to giving investigational products
• Acute physiology and chronic health evaluation II score more than 10
• Aged between 60 to 80 years old
• Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight

Exclusion criteria

• Trauma and burn patients
• Any kind of dialysis
• Suspected or confirmed difficult airway
• Use of neuromuscular blocking drugs(Except using for intubation )
• Neuromuscular disease
• Epidural or subarachnoid anesthesia
• Plan to give general anesthesia before 24 hours drugs intervention or after giving investigational drugs
• Serious central nervous system disease
• Mental disability or mental disease
• Acute hepatitis and serious liver disease(Child-Pugh C)
• Unstable angina and acute myocardium infarction
• Left ventricular ejection volume less than 30%,heart rate less than 50 beats per minute
• II and III degree atrioventricular block
• Systolic pressure less than 90 mmHg after giving vasopressors twice before beginning of this study
• Consciousness disturbance patients whose blood pressure less than 70mmHg and blood lactate more than 4.0mmol/L
• Suspected or confirmed long term use of narcotic analgesics
• Subjects who are breastfeeding or pregnant
• Allergic to investigational products or with other contraindication
• Participated in other study within 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group dexmedetomidine ,dexmedetomidine

Experimental group

Description:

Continuous pump infusion dexmedetomidine with loading dose of 0.4μg.kg-1 for 10 minutes ,then followed by maintenance dose of 0.2\~0.7µg.kg-1 to maintain Sedation-Agitation Scale between 3 and 4.

Treatment:

Drug: Dexmedetomidine

Group midazolam,midazolam,fentanyl

Active Comparator group

Description:

Quickly inject midazolam and fentanyl with loading dose of 0.1mg.kg-1 and 1 μg.kg-1 separately until attaining Sedation-Agitation Scale between 3 and 4,then followed by maintenance dose of 0.05\~0.1mg.kg-1.h-1 and fentanyl 0.5\~1μg.kg-1.h-1 separately.

Treatment:

Drug: Midazolam

Drug: Fentanyl