CClinicalTrials.gg
Status unknownNCT02224443Updated Aug 25, 2014

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

A Phase 4 interventional study of dexmedetomidine and dexmedetomidine in Postoperative Cognitive Dysfunction, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-08-25.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Postoperative Cognitive Dysfunction

Keywords

  • Dexmedetomidine,postoperative cognitive dysfunction
03

In context

Postoperative Cognitive Complications

264 studies on the registry are indexed under Postoperative Cognitive Complications; 54 are open to participants now.

This study's planned enrollment of 90 is below the median of 110 across 147 interventional studies indexed under Postoperative Cognitive Complications.

Browse Postoperative Cognitive Complications studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    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

    Drug: dexmedetomidine · Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate · Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

  • Experimental
    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

    Drug: dexmedetomidine · Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate · Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

  • Placebo comparator
    Group C ,normal saline

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

    Drug: normal saline · Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate · Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane

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

  • Drugdexmedetomidine

    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

  • 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%

06

What researchers measure

Primary outcomes

  1. Change from baseline to postoperation in cognitive function

    Mini-mental State Examination

    Time frame: One day before operation,third day after operation,sixth day after operaion

  2. Change from baseline to postoperation in recent memory

    Rey Auditory Verbal Learning Test

    Time frame: One day before operation,third day after operation,sixth day after operation

  3. Change from baseline to postoperation in visual space and directional force

    Trail Making Test A,Trail Making Test B

    Time frame: One day before operation,third day after operation,sixth day after operaion

  4. Change from baseline to postoperation in attention

    Digit Span Test

    Time frame: One day before operation,third day after operation,sixth day after operaion

  5. Change from baseline to postoperation in pain scores

    Visual analog scales

    Time frame: One day before operation,third day after operation,sixth day after operation

  6. Change from baseline to postoperation in depression scale

    Beck Depression Inventory

    Time frame: One day before operation,third day after operation,sixth day after operation

Secondary outcomes

  1. The duration of operation

    Time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours

  2. The blood volume during the operation

    Time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours

  3. The urine volume during operation

    Time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours

  4. The dose of drugs used during operation

    The dose of ephedrine, urapidil, atropine used during operation

    Time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02224443
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Ma Zhengmin (Anaesthetist, First Affiliated Hospital Xi'an Jiaotong University) — Principal investigator
First posted
Aug 25, 2014
Start date
Sep 2014
Primary completion
Aug 2015 (estimated)
Completion
Sep 2015 (estimated)
Last update
Aug 25, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion