Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- dexmedetomidine
- Conditions
- Postoperative Cognitive Dysfunction
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Enrollment
- 90
- Primary Endpoint
- Change from baseline to postoperation in cognitive function
- Last Updated
- 11 years ago
Overview
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
Investigators
Ma Zhengmin
Anaesthetist
First Affiliated Hospital Xi'an Jiaotong University
Eligibility Criteria
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
Arms & Interventions
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
Intervention: dexmedetomidine
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
Intervention: midazolam,fentanyl,etomidate,Cisatracurium besylate
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
Intervention: cisatracurium besylate,propofol,remifentanil,sevoflurane
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
Intervention: dexmedetomidine
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
Intervention: midazolam,fentanyl,etomidate,Cisatracurium besylate
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
Intervention: cisatracurium besylate,propofol,remifentanil,sevoflurane
Group C ,normal saline
Normal saline infusion will be given with the same infusion volume as group A and B
Intervention: normal saline
Group C ,normal saline
Normal saline infusion will be given with the same infusion volume as group A and B
Intervention: midazolam,fentanyl,etomidate,Cisatracurium besylate
Group C ,normal saline
Normal saline infusion will be given with the same infusion volume as group A and B
Intervention: cisatracurium besylate,propofol,remifentanil,sevoflurane
Outcomes
Primary Outcomes
Change from baseline to postoperation in cognitive function
Time Frame: One day before operation,third day after operation,sixth day after operaion
Mini-mental State Examination
Change from baseline to postoperation in recent memory
Time Frame: One day before operation,third day after operation,sixth day after operation
Rey Auditory Verbal Learning Test
Change from baseline to postoperation in depression scale
Time Frame: One day before operation,third day after operation,sixth day after operation
Beck Depression Inventory
Change from baseline to postoperation in visual space and directional force
Time Frame: One day before operation,third day after operation,sixth day after operaion
Trail Making Test A,Trail Making Test B
Change from baseline to postoperation in attention
Time Frame: One day before operation,third day after operation,sixth day after operaion
Digit Span Test
Change from baseline to postoperation in pain scores
Time Frame: One day before operation,third day after operation,sixth day after operation
Visual analog scales
Secondary Outcomes
- The urine volume during operation(From begining of cutting skin to the end of skin closure,an expected average of 3 hours)
- 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 dose of drugs used during operation(From begining of cutting skin to the end of skin closure,an expected average of 3 hours)