Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients
Phase 4
- Conditions
- Postoperative Cognitive Dysfunction
- Interventions
- Drug: normal salineDrug: midazolam,fentanyl,etomidate,Cisatracurium besylate
- Registration Number
- NCT02224443
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A, dexmedetomidine , 0.3µg.kg-1.h-1 midazolam,fentanyl,etomidate,Cisatracurium besylate 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 C ,normal saline normal saline 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 Normal saline infusion will be given with the same infusion volume as group A and B Group A, dexmedetomidine , 0.3µg.kg-1.h-1 dexmedetomidine 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 cisatracurium besylate,propofol,remifentanil,sevoflurane 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 C ,normal saline cisatracurium besylate,propofol,remifentanil,sevoflurane Normal saline infusion will be given with the same infusion volume as group A and B Group B,dexmedetomidine , 0.5µg.kg-1.h-1 midazolam,fentanyl,etomidate,Cisatracurium besylate 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 Group B,dexmedetomidine , 0.5µg.kg-1.h-1 cisatracurium besylate,propofol,remifentanil,sevoflurane 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 Group B,dexmedetomidine , 0.5µg.kg-1.h-1 dexmedetomidine 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
- Primary Outcome Measures
Name Time Method Change from baseline to postoperation in cognitive function One day before operation,third day after operation,sixth day after operaion Mini-mental State Examination
Change from baseline to postoperation in recent memory 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 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 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 One day before operation,third day after operation,sixth day after operaion Digit Span Test
Change from baseline to postoperation in pain scores One day before operation,third day after operation,sixth day after operation Visual analog scales
- Secondary Outcome Measures
Name Time Method 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 The dose of ephedrine, urapidil, atropine used during operation