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

NCT02225210 | Unknown Phase 4

• 1 other identifier: Shu 2014
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Keywords

Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• Changes in blood pressure within 48 hours after drug intervention

  Within 48 hours after drug intervention

• Number of Participants with blood pressure decrease more than 20% of the baseline value or systolic pressure less than 100 mmHg

  within 48 hours afer drug intervention

• The number of cases who develop delirium

  Within 48 hours after drug intervention

Secondary Outcomes (3)

• Changes in heart rate

  Within 48 hours after drug intervention

• Changes in respiratory rate

  Within 48 hours after drug intervention

• Changes in central venous pressure

  Within 48 hours after drug intervention

Study Arms (2)

Group dexmedetomidine ,dexmedetomidine

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Group midazolam,midazolam,fentanyl

ACTIVE COMPARATOR

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.

Drug: Midazolam; Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

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

Group dexmedetomidine ,dexmedetomidine

Midazolam 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

Group midazolam,midazolam,fentanyl

Fentanyl 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

Group midazolam,midazolam,fentanyl

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuling Central Hospital of Chongqing City: lead

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 26, 2014

Record last verified: 2014-08