Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients

Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study

The purpose of this study is to identify the effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients

Study Overview

• Status: Unknown
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Drug: dexmedetomidine; Drug: dexmedetomidine; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane; Drug: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Elective gastrointestinal surgery
• American Society of Anesthesiologists class II to III
• Aged between 65 and 80 years old
• Weight between 45 and 75 kilogram,Body Mass Index between 19 and 24 kg.m-2
• With primary hypertension reaching or more than 1 year
• Normal cognitive function,mini-mental state examination more than 27

Exclusion Criteria:

• Severe arrhythmia,atrioventricular block and secondary hypertension
• Liver and kidney dysfunction,pulmonary disease,endocrine disease
• Suspected or confirmed difficult airway
• Any disease or pathologic change will interfere study result
• Inability to exchange with serious visual and hearing impairment
• Long term use of sedative-hypnotic drugs and antidepressant drug
• Addicted to alcohol, tobacco or drug
• Neuromuscular disease
• Suspected of malignant hyperthermia
• 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: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A, dexmedetomidine , 0.3µg.kg-1.h-1; Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed Continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation	Drug: dexmedetomidine; Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation; Drug: dexmedetomidine; Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane; Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
Experimental: Group B,dexmedetomidine , 0.5µg.kg-1.h-1; Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation	Drug: dexmedetomidine; Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation; Drug: dexmedetomidine; Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane; Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
Placebo Comparator: Group C ,normal saline; Normal saline infusion will be given with the same infusion volume as group A and B	Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane; Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%; Drug: normal saline; Group C , Normal saline infusion will be given with the same infusion volume as group A and B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to postoperation in cognitive function	Mini-mental State Examination	One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in recent memory	Rey Auditory Verbal Learning Test	One day before operation,third day after operation,sixth day after operation
Change from baseline to postoperation in visual space and directional force	Trail Making Test A,Trail Making Test B	One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in attention	Digit Span Test	One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in pain scores	Visual analog scales	One day before operation,third day after operation,sixth day after operation
Change from baseline to postoperation in depression scale	Beck Depression Inventory	One day before operation,third day after operation,sixth day after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of operation		From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The blood volume during the operation		From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The urine volume during operation		From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The dose of drugs used during operation	The dose of ephedrine, urapidil, atropine used during operation	From begining of cutting skin to the end of skin closure,an expected average of 3 hours

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Estimate): August 25, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Dexmedetomidine,postoperative cognitive dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Platelet Aggregation Inhibitors; 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; Anesthetics, Inhalation; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Remifentanil; Fentanyl; Midazolam; Propofol; Dexmedetomidine; Sevoflurane; Etomidate; Cisatracurium; Atracurium
• Other Study ID Numbers: Ma sedation