Postoperative ConfusionPhase 4NCT02275182
Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients
A Phase 4 study testing Dexmedetomidine and Saline in people with Postoperative Confusion and Delirium, run by The First Affiliated Hospital of Anhui Medical University at 13 sites in China.
Trial summary
Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Confusion, Delirium
- What is being tested?
- Dexmedetomidine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 864 participants
- Where
- 13 sitesChina
- Study dates
- Oct 2014to 20 Feb 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Written informed consent
- Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred）；
- Age 65-90 yrs；
- Anesthesia Society of American (ASA) Scale II~III；
- Anticipated surgery time 2-6 hrs； -
Who cannot join
- Dementia patients（Mini-mental state examination< 20）
- Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction；
- Unstable metal status and mental disease；
- The cognitive function examination in 3-6 months is not anticipated to be completed
- II-III Atrioventricular block；
- Heat rate < 50 beats/minutes；
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- Parkinson's Disease；
- May occur or have occurred the difficult airway or anticipated delayed extubation
- Sure or suspected abuse of analgesic and sedation drug；
- Allergic to the trial drug and other anesthesia drug contraindication； -
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Anqing Municipal Hospital
Anqing, Anhui
Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Affiliated Chaohu Hospital of Anhui Medical Hospital
Chaohu, Anhui
Binhu Hospital of Hefei
Hefei, Anhui
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The first Hospital of Hefei
Hefei, Anhui
The Second Hospital of Hefei
Hefei, Anhui
The Second People's Hospital of Anhui
Hefei, Anhui
the people's Hospital of Liuan
Liuan, Anhui
the people's Hospital of Tongling
Tongling, Anhui
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
The second People's Hospital of Wuhu
Wuhu, Anhui
About this study
Official title: Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction--a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.
Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test.
Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.
- Conditions
- Postoperative Confusion, Delirium
- Being tested
- Dexmedetomidine, Saline
- Keywords
- Dexmedetomidine
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Yisi
0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
SalineDrug
0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over. Receives: Drug: Dexmedetomidine |
| Controlled | Placebo comparator | 0.5μg/kg Saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of incidence of postoperative cognition dysfunction
- The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively.
- A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min.
- Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(ΔXc), and the standard deviation(SD) of the difference.
- Calculate the difference(ΔX) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ΔX) divided by the standard deviation（SD）of the difference of the normal population, that is ΔX / SD and it is the Z score.
- POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores ≥1.96, the POCD is exist.
Measured: 1 day Before surgery,the 3rd,7th day after the surgery.
The change of incidence of postoperative delirium
Through CAM-ICU to assess the incidence of the postoperative delirium.
Measured: The first, second and third day after the surgery.
The change of Neuropsychological status
Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up.
Measured: the 3rd,6th month after the surgery
Secondary outcomes (7)
The occurrence of cardiovascular events.
Measured: from begging of the anesthesia to the time the patients discharge, up to 1 month.
The incidence of any adverse or severe adverse events.
Including kidney or brain related adverse events.
Measured: From the beginning of the admitted to 6 month after the surgery, up to 6 month.
The variation of heart rate.
Heart rate is recorded every 15 minutes during the anesthesia.
Measured: From the beginning to the end of anesthesia,up to 6 hours.
The variation of blood pressure.
blood pressure is recorded every 15 minutes during the anesthesia.
Measured: From the beginning to the end of anesthesia,up to 6 hours.
the variation of pulse oxygen saturation.
Pulse oxygen saturation is recorded every 15 minutes during the anesthesia.
Measured: From the beginning to the end of anesthesia,up to 6 hours.
The monitor of depth of anesthesia.
Bispectral index (Bis) is recorded every 15 minutes during the anesthesia.
Measured: From the beginning to the end of anesthesia,up to 6 hours.
The serum concentrations of BDNF
Serum level of brain-derived neurotrophic factor (BDNF) was measured
Measured: From the baseline to the 3-day,7-day and 1-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2017
- Study completion20 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ConfusionStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 864 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinqi Cheng, The First Affiliated Hospital of Anhui Medical University
- Investigators
- Wei Er Gu, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275182
- Sponsor's protocol ID
- 201401
- Status last verified
- Apr 2018
- First submitted
- 21 Oct 2014
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction--a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT02275182
- Acronym / sponsor ID
- 201401
- Conditions
- Postoperative Confusion, Delirium
- Keywords
- Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 20 Feb 2017 (actual)
- First posted
- 27 Oct 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.
Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test.
Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over. |
| Controlled | Placebo comparator | Drug: Saline0.5μg/kg Saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred）；
- Age 65-90 yrs；
- Anesthesia Society of American (ASA) Scale II~III；
- Anticipated surgery time 2-6 hrs； -
Key exclusion criteria (10 listed)
- Dementia patients（Mini-mental state examination< 20）
- Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction；
- Unstable metal status and mental disease；
- The cognitive function examination in 3-6 months is not anticipated to be completed
- II-III Atrioventricular block；
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 |
|---|---|---|
| DexmedetomidineAlso: Yisi0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over. | Drug | Dexmedetomidine |
| Saline0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over. | Drug | Controlled |
Primary outcome
The change of incidence of postoperative cognition dysfunction
Time frame: 1 day Before surgery,the 3rd,7th day after the surgery.
1. The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively. 2. A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min. 3. Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(ΔXc), and the standard deviation(SD) of the difference. 4. Calculate the difference(ΔX) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ΔX) divided by the standard deviation（SD）of the difference of the normal population, that is ΔX / SD and it is the Z score. 5. POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores ≥1.96, the POCD is exist.
The change of incidence of postoperative delirium
Time frame: The first, second and third day after the surgery.
Through CAM-ICU to assess the incidence of the postoperative delirium.
The change of Neuropsychological status
Time frame: the 3rd,6th month after the surgery
Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up.
7 secondary outcomes
The occurrence of cardiovascular events.
Time frame: from begging of the anesthesia to the time the patients discharge, up to 1 month.
The incidence of any adverse or severe adverse events.
Time frame: From the beginning of the admitted to 6 month after the surgery, up to 6 month.
The variation of heart rate.
Time frame: From the beginning to the end of anesthesia,up to 6 hours.
The variation of blood pressure.
Time frame: From the beginning to the end of anesthesia,up to 6 hours.
the variation of pulse oxygen saturation.
Time frame: From the beginning to the end of anesthesia,up to 6 hours.
The monitor of depth of anesthesia.
Time frame: From the beginning to the end of anesthesia,up to 6 hours.
The serum concentrations of BDNF
Time frame: From the baseline to the 3-day,7-day and 1-month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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.
Wei Er Gu principal investigator
The First Affiliated Hospital of Anhui Medical University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Saline in people with Postoperative Confusion and Delirium, run by The First Affiliated Hospital of Anhui Medical University at 13 sites in China.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change of incidence of postoperative cognition dysfunction (time frame: 1 day Before surgery,the 3rd,7th day after the surgery.). The study lists 3 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 Apr 2018.