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

Effects of Dexmedetomidine Sedation on Delirium and Haemodynamic in Mechanical Ventilated Elderly Patients -a Single Center,Randomized and Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Safety of Dexmedetomidine Sedation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dexmedetomidine; Loading dose:0.4μg.kg-1 Maintenance dose :0.2~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.
Active Comparator: 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.	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fuling Central Hospital of Chongqing City

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 24, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Estimate): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 24, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Dexmedetomidine ,Delirium ,Haemodynamic, Mechanical ventilation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; 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, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Dexmedetomidine
• Other Study ID Numbers: Shu 2014