DeliriumPhase 4KeCoDyNCT02782429
The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
A Phase 4 study testing Ketamine and Saline in people with Delirium and Inflammation, run by Flavia orange at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze the Ketamine with its anti-inflammatory profile would be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since these disorders contribute to an impact on morbidity / mortality in this population. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Delirium, Inflammation, Cognitive Disorders
- What is being tested?
- Ketamine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to May 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 50 years.
- Be submitted to cardiac surgery by sternotomy and with the use of cardiopulmonary bypass (CPB).
- American Society of Anesthesiologists classification 1, 2,3 and 4.
Who cannot join
- Patients undergoing reoperation.
- Patients undergoing heart transplantation.
- Patients using vasopressor agents and / or ionotropic continuous preoperatively.
- Patients with prior endotracheal intubation and consequently Ventilatory Assistance Mechanics.
- Patients with documented psychiatric disorders.
- Patients with previous cognitive disorders.
- Patients with a history of alcohol or drug abuse.
- Patients with a history of cerebrovascular accident (CVA) with less than 3 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Medicina Integral Prof Fernando Figueira
Recife, Pernambuco, 50070-550
Flávia A de Orange, PhD, + 55 81 994197979, orangeflavia@gmail.com
Rebeca GA Andrade, master, +55 81 988043844, bekinhagonelli@hotmail.com
About this study
The purpose of this study is to analyze the Ketamine with its anti-inflammatory profile would be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since these disorders contribute to an impact on morbidity / mortality in this population.
- Conditions
- Delirium, Inflammation, Cognitive Disorders, Amnestic, Dementia
- Being tested
- Ketamine, Saline
- Keywords
- ketamine, Cardiac Surgery, Neurocognitive Disorders
- Medical subject headings
- Delirium, Inflammation, Cognitive Dysfunction, Dementia, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | This group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized. Receives: Drug: Ketamine |
| Placebo | Placebo comparator | This group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
Measured: Baseline and 7 days
Detectable levels of inflammatory biomarkers in bloodstream, such as: P-selectin (CD62p- ng/ml), CD40L soluble (ng/ml), s100B (ng/ml)
Measured: Change from baseline at 6 hours and 24 hours after surgery
Secondary outcomes (2)
Delirium assessed using the Confusion Assessment Method (CAM)
Measured: 24 hours after surgery
Sternotomy Pain assessed using the Visual Analogue Scale
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flavia orange
- Sponsor type
- University, hospital or other
- Collaborators
- Rebeca Gonelli Albanez da Cunha Andrade
- Responsible party
- Sponsor-investigator, Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Rebeca GA Andrade, master, Principal investigator, Instituto de Medicina Integral Prof Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782429
- Sponsor's protocol ID
- IMIP
- Acronym
- KeCoDy
- Status last verified
- May 2016
- First submitted
- 19 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
Publications
Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Byrne AJ, Hudetz AG, Pagel PS, Warltier DC. Ketamine attenuates post-operative cognitive dysfunction after cardiac surgery. Acta Anaesthesiol Scand. 2009 Aug;53(7):864-72. doi: 10.1111/j.1399-6576.2009.01978.x. Epub 2009 Apr 28.
PubMed 19422355Cata JP, Abdelmalak B, Farag E. Neurological biomarkers in the perioperative period. Br J Anaesth. 2011 Dec;107(6):844-58. doi: 10.1093/bja/aer338. Epub 2011 Nov 6.
PubMed 22065690Dale O, Somogyi AA, Li Y, Sullivan T, Shavit Y. Does intraoperative ketamine attenuate inflammatory reactivity following surgery? A systematic review and meta-analysis. Anesth Analg. 2012 Oct;115(4):934-43. doi: 10.1213/ANE.0b013e3182662e30. Epub 2012 Jul 23.
PubMed 22826531Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
PubMed 39428602
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ketamine in Preventing Cognitive Dysfunctions in Postoperative Period of Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02782429
- Acronym / sponsor ID
- KeCoDy / IMIP
- Conditions
- Delirium, Inflammation, Cognitive Disorders, Amnestic, Dementia
- Keywords
- ketamine, Cardiac Surgery, Neurocognitive Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Flavia orangeUniversity, hospital or other
- Collaborators
- Rebeca Gonelli Albanez da Cunha Andrade
- Study start
- Apr 2016
- Primary completion
- May 2017 (estimated)
- First posted
- 25 May 2016 (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 analyze the Ketamine with its anti-inflammatory profile would be able to prevent cognitive disorders in the postoperative period of cardiac surgery, since these disorders contribute to an impact on morbidity / mortality in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineThis group received ketamine in a dose 0.5 mg / in anesthesia, in addition to other drugs used for induction, which will be standardized. |
| Placebo | Placebo comparator | Other: SalineThis group received the equivalent volume of saline, in addition to other drugs used for induction, which will be standardized. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged over 50 years.
- Be submitted to cardiac surgery by sternotomy and with the use of cardiopulmonary bypass (CPB).
- American Society of Anesthesiologists classification 1, 2,3 and 4.
Key exclusion criteria (8 listed)
- Patients undergoing reoperation.
- Patients undergoing heart transplantation.
- Patients using vasopressor agents and / or ionotropic continuous preoperatively.
- Patients with prior endotracheal intubation and consequently Ventilatory Assistance Mechanics.
- Patients with documented psychiatric disorders.
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 |
|---|---|---|
| Ketamine | Drug | Ketamine |
| Saline | Other | Placebo |
Primary outcome
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination
Time frame: Baseline and 7 days
Detectable levels of inflammatory biomarkers in bloodstream, such as: P-selectin (CD62p- ng/ml), CD40L soluble (ng/ml), s100B (ng/ml)
Time frame: Change from baseline at 6 hours and 24 hours after surgery
2 secondary outcomes
Delirium assessed using the Confusion Assessment Method (CAM)
Time frame: 24 hours after surgery
Sternotomy Pain assessed using the Visual Analogue Scale
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Results publication: PubMed 19422355Hudetz JA, Iqbal Z, Gandhi SD, Patterson KM, Byrne AJ, Hudetz AG, Pagel PS, Warltier DC. Ketamine attenuates post-operative cognitive dysfunction after cardiac surgery. Acta Anaesthesiol Scand. 2009 Aug;53(7):864-72. doi: 10.1111/j.1399-6576.2009.01978.x. Epub 2009 Apr 28.
- Results publication: PubMed 22065690Cata JP, Abdelmalak B, Farag E. Neurological biomarkers in the perioperative period. Br J Anaesth. 2011 Dec;107(6):844-58. doi: 10.1093/bja/aer338. Epub 2011 Nov 6.
- Results publication: PubMed 22826531Dale O, Somogyi AA, Li Y, Sullivan T, Shavit Y. Does intraoperative ketamine attenuate inflammatory reactivity following surgery? A systematic review and meta-analysis. Anesth Analg. 2012 Oct;115(4):934-43. doi: 10.1213/ANE.0b013e3182662e30. Epub 2012 Jul 23.
- Derived from this study: PubMed 39428602Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20.
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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.
Rebeca GA Andrade, master principal investigator
Instituto de Medicina Integral Prof Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Saline in people with Delirium and Inflammation, run by Flavia orange at 1 site in Brazil.
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 3 inclusion and 8 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 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebeca GA Andrade, master (+55 81 988043844, bekinhagonelli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive disorder, defined by a drop of 2 points in the Mini-Mental State Examination (time frame: Baseline and 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782429, which also lists 4 linked publications.
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 May 2016.