Postoperative Cognitive DysfunctionPhase 4NCT02224443
Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients
A Phase 4 study testing dexmedetomidine, normal saline and midazolam,fentanyl,etomidate,Cisatracurium besylate in people with Postoperative Cognitive Dysfunction, run by First Affiliated Hospital Xi'an Jiaotong University.
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 Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- dexmedetomidine, normal saline and midazolam,fentanyl,etomidate,Cisatracurium besylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study
The purpose of this study is to identify the effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- dexmedetomidine, normal saline, midazolam,fentanyl,etomidate,Cisatracurium besylate, cisatracurium besylate,propofol,remifentanil,sevoflurane
- Keywords
- Dexmedetomidine,postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
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
dexmedetomidineDrug
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 salineDrug
Group C , Normal saline infusion will be given with the same infusion volume as group A and B
midazolam,fentanyl,etomidate,Cisatracurium besylateDrug
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,sevofluraneDrug
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%
| Study group | Role | What they receive |
|---|---|---|
| Group A, dexmedetomidine , 0.3µg.kg-1.h-1 | Experimental | 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 Receives: Drug: dexmedetomidine; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane |
| Group B,dexmedetomidine , 0.5µg.kg-1.h-1 | Experimental | 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 Receives: Drug: dexmedetomidine; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane |
| Group C ,normal saline | Placebo comparator | Normal saline infusion will be given with the same infusion volume as group A and B Receives: Drug: normal saline; Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate; Drug: cisatracurium besylate,propofol,remifentanil,sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to postoperation in cognitive function
Mini-mental State Examination
Measured: One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in recent memory
Rey Auditory Verbal Learning Test
Measured: One day before operation,third day after operation,sixth day after operation
Change from baseline to postoperation in visual space and directional force
Trail Making Test A,Trail Making Test B
Measured: One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in attention
Digit Span Test
Measured: One day before operation,third day after operation,sixth day after operaion
Change from baseline to postoperation in pain scores
Visual analog scales
Measured: One day before operation,third day after operation,sixth day after operation
Change from baseline to postoperation in depression scale
Beck Depression Inventory
Measured: One day before operation,third day after operation,sixth day after operation
Secondary outcomes (4)
The duration of operation
Measured: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The blood volume during the operation
Measured: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The urine volume during operation
Measured: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The dose of drugs used during operation
The dose of ephedrine, urapidil, atropine used during operation
Measured: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Zhengmin, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224443
- Sponsor's protocol ID
- Ma sedation
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients-A Single Center,Randomized, Double-blinded,Controlled Study
- ClinicalTrials.gov ID
- NCT02224443
- Acronym / sponsor ID
- Ma sedation
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Dexmedetomidine,postoperative cognitive dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the effects of different doses of dexmedetomidine on postoperative cognitive dysfunction in elderly hypertensive patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A, dexmedetomidine , 0.3µg.kg-1.h-1 | Experimental | Drug: dexmedetomidine, Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate, Drug: cisatracurium besylate,propofol,remifentanil,sevofluraneContinuous 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 B,dexmedetomidine , 0.5µg.kg-1.h-1 | Experimental | Drug: dexmedetomidine, Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate, Drug: cisatracurium besylate,propofol,remifentanil,sevofluraneContinuous 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 C ,normal saline | Placebo comparator | Drug: normal saline, Drug: midazolam,fentanyl,etomidate,Cisatracurium besylate, Drug: cisatracurium besylate,propofol,remifentanil,sevofluraneNormal saline infusion will be given with the same infusion volume as group A and B |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineExperimental: 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 | Drug | Group A, dexmedetomidine , 0.3µg.kg-1.h-1 |
| dexmedetomidineGroup 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 | Drug | Group B,dexmedetomidine , 0.5µg.kg-1.h-1 |
| normal salineGroup C , Normal saline infusion will be given with the same infusion volume as group A and B | Drug | Group C ,normal saline |
| midazolam,fentanyl,etomidate,Cisatracurium besylateAnesthesia 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 | Drug | Group A, dexmedetomidine , 0.3µg.kg-1.h-1, Group B,dexmedetomidine , 0.5µg.kg-1.h-1, Group C ,normal saline |
| cisatracurium besylate,propofol,remifentanil,sevofluraneMaintenance 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% | Drug | Group A, dexmedetomidine , 0.3µg.kg-1.h-1, Group B,dexmedetomidine , 0.5µg.kg-1.h-1, Group C ,normal saline |
Primary outcome
Change from baseline to postoperation in cognitive function
Time frame: One day before operation,third day after operation,sixth day after operaion
Mini-mental State Examination
Change from baseline to postoperation in recent memory
Time frame: One day before operation,third day after operation,sixth day after operation
Rey Auditory Verbal Learning Test
Change from baseline to postoperation in visual space and directional force
Time frame: 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
Time frame: One day before operation,third day after operation,sixth day after operaion
Digit Span Test
Change from baseline to postoperation in pain scores
Time frame: One day before operation,third day after operation,sixth day after operation
Visual analog scales
Change from baseline to postoperation in depression scale
Time frame: One day before operation,third day after operation,sixth day after operation
Beck Depression Inventory
4 secondary outcomes
The duration of operation
Time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
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
The urine volume during operation
Time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
The dose of drugs used during operation
Time frame: From begining of cutting skin to the end of skin closure,an expected average of 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine, normal saline and midazolam,fentanyl,etomidate,Cisatracurium besylate in people with Postoperative Cognitive Dysfunction, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to postoperation in cognitive function (time frame: One day before operation,third day after operation,sixth day after operaion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.