Clinical trial NCT02224443: Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients
Official title: Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction
Keywords: Dexmedetomidine,postoperative cognitive dysfunction
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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
* Participated in other study within 30 days

Primary outcomes:
measure: Change from baseline to postoperation in cognitive function
timeFrame: One day before operation,third day after operation,sixth day after operaion
measure: Change from baseline to postoperation in recent memory
timeFrame: One day before operation,third day after operation,sixth day after operation
measure: Change from baseline to postoperation in visual space and directional force
timeFrame: One day before operation,third day after operation,sixth day after operaion
measure: Change from baseline to postoperation in attention
timeFrame: One day before operation,third day after operation,sixth day after operaion
measure: Change from baseline to postoperation in pain scores
timeFrame: One day before operation,third day after operation,sixth day after operation
measure: Change from baseline to postoperation in depression scale
timeFrame: One day before operation,third day after operation,sixth day after operation
Secondary outcomes:
measure: The duration of operation
timeFrame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
measure: The blood volume during the operation
timeFrame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
measure: The urine volume during operation
timeFrame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
measure: The dose of drugs used during operation
timeFrame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
Other outcomes:
Locations:
Study officials:
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