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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02224443
Enrollment
90
Registered
2014-08-25
Start date
2014-09-30
Completion date
2015-09-30
Last updated
2014-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

Dexmedetomidine,postoperative cognitive dysfunction

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

Interventions

DRUGdexmedetomidine

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

DRUGnormal saline

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

DRUGmidazolam,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

DRUGcisatracurium 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%

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline to postoperation in depression scaleOne day before operation,third day after operation,sixth day after operationBeck Depression Inventory
Change from baseline to postoperation in recent memoryOne day before operation,third day after operation,sixth day after operationRey Auditory Verbal Learning Test
Change from baseline to postoperation in visual space and directional forceOne day before operation,third day after operation,sixth day after operaionTrail Making Test A,Trail Making Test B
Change from baseline to postoperation in attentionOne day before operation,third day after operation,sixth day after operaionDigit Span Test
Change from baseline to postoperation in pain scoresOne day before operation,third day after operation,sixth day after operationVisual analog scales
Change from baseline to postoperation in cognitive functionOne day before operation,third day after operation,sixth day after operaionMini-mental State Examination

Secondary

MeasureTime frameDescription
The blood volume during the operationFrom begining of cutting skin to the end of skin closure,an expected average of 3 hours
The urine volume during operationFrom begining of cutting skin to the end of skin closure,an expected average of 3 hours
The dose of drugs used during operationFrom begining of cutting skin to the end of skin closure,an expected average of 3 hoursThe dose of ephedrine, urapidil, atropine used during operation
The duration of operationFrom begining of cutting skin to the end of skin closure,an expected average of 3 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026