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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02224443
• Other study ID #: Ma sedation
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 21, 2014
• Last updated: August 21, 2014
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2014
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to postoperation in cognitive function	Mini-mental State Examination	One day before operation,third day after operation,sixth day after operaion	No
Primary	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	No
Primary	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	No
Primary	Change from baseline to postoperation in attention	Digit Span Test	One day before operation,third day after operation,sixth day after operaion	No
Primary	Change from baseline to postoperation in pain scores	Visual analog scales	One day before operation,third day after operation,sixth day after operation	No
Primary	Change from baseline to postoperation in depression scale	Beck Depression Inventory	One day before operation,third day after operation,sixth day after operation	No
Secondary	The duration of operation		From begining of cutting skin to the end of skin closure,an expected average of 3 hours	Yes
Secondary	The blood volume during the operation		From begining of cutting skin to the end of skin closure,an expected average of 3 hours	Yes
Secondary	The urine volume during operation		From begining of cutting skin to the end of skin closure,an expected average of 3 hours	Yes
Secondary	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	Yes