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

NCT02224443 | Unknown Phase 4 DMC

• 1 other identifier: Ma sedation
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Cognitive Dysfunction

Keywords

Dexmedetomidine,postoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

  From begining of cutting skin to the end of skin closure,an expected average of 3 hours

Study Arms (3)

Group A, dexmedetomidine , 0.3µg.kg-1.h-1

EXPERIMENTAL

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; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

Group B,dexmedetomidine , 0.5µg.kg-1.h-1

EXPERIMENTAL

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; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

Group C ,normal saline

PLACEBO COMPARATOR

Normal saline infusion will be given with the same infusion volume as group A and B

Drug: normal saline; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

Interventions

dexmedetomidine DRUG

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

Group A, dexmedetomidine , 0.3µg.kg-1.h-1

normal saline DRUG

Group C , Normal saline infusion will be given with the same infusion volume as group A and B

Group C ,normal saline

midazolam,fentanyl,etomidate,Cisatracurium besylate DRUG

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

Group A, dexmedetomidine , 0.3µg.kg-1.h-1; Group B,dexmedetomidine , 0.5µg.kg-1.h-1; Group C ,normal saline

cisatracurium besylate,propofol,remifentanil,sevoflurane DRUG

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%

Group A, dexmedetomidine , 0.3µg.kg-1.h-1; Group B,dexmedetomidine , 0.5µg.kg-1.h-1; Group C ,normal saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Dexmedetomidine; Saline Solution; Midazolam; cisatracurium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthetist

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 25, 2014

Record last verified: 2014-08