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

NCT ID: NCT02225210

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-07-31

Brief Summary

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.

Conditions

Safety of Dexmedetomidine Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group dexmedetomidine ,dexmedetomidine

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.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Loading dose:0.4μg.kg-1 Maintenance dose :0.2\~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.

Group midazolam,midazolam,fentanyl

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.

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

Loading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05\~0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4

Fentanyl

Intervention Type: DRUG

Loading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5\~1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4

Interventions

Dexmedetomidine

Loading dose:0.4μg.kg-1 Maintenance dose :0.2\~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.

Intervention Type: DRUG

Midazolam

Loading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05\~0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4

Intervention Type: DRUG

Fentanyl

Loading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5\~1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuling Central Hospital of Chongqing City

OTHER

Sponsor Role: lead

Responsible Party

Shuaiya

physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Shu 2014

Identifier Type: -

Identifier Source: org_study_id