Postoperative Cognitive DysfunctionPhase 4NCT01332812
Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction
A Phase 4 study testing Dexamethasone in people with Postoperative Cognitive Dysfunction, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Mar 2013
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 60 years,
- underwent surgery for inguinal hernia repair, Nissen procedure, cholecystectomy or other surgeries midsize under general anesthesia and hospital stay expected within 72 hours.
Who cannot join
- age less than 60 years,
- history of brain disease or dementia, other psychiatric disorders that affect cognition,
- lack of proficiency in Portuguese,
- use of corticosteroids or opioid preoperatively.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital of the University of São Paulo Medical School
São Paulo, São Paulo, 05403-000
About this study
Official title: Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia
This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.
Read the detailed description
Postoperative cognitive dysfunction is related with the use of opioids in the postoperative period, lack of physical activity, fatigue, postoperative pain and quality of life. The use of corticosteroids preoperatively reduces postoperative pain, fatigue, nausea and vomiting in the postoperative period and is frequently used as an adjuvant in anesthesia. This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Dexamethasone, control group
- Keywords
- Dexamethasone, Postoperative cognitive dysfunction, General Anesthesia, neuropsychological tests
- 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.
DexamethasoneDrug
Also called The Dexamethasone and Index Bispectral
a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
control groupOther
Also called Index Bispectral and not received the Desamethasone
General anesthesia, without additional interventions
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone, POCD, psycological tests | Experimental | Subjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered.
Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery. Receives: Drug: Dexamethasone |
| Control, POCD, psycological tests | Sham comparator | Subjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered.
Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in neuropsycological tests.
Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Duke University
- Responsible party
- Principal investigator, Maria José Carvalho Carmona, University of Sao Paulo
- Investigators
- Maria José C Carmona, M.D., Principal investigator, Faculty of Medicine of the University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332812
- Sponsor's protocol ID
- Maria J.C. Carmona
- Status last verified
- Sep 2015
- First submitted
- 7 Apr 2011
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Valentin LS, Pereira VF, Pietrobon RS, Schmidt AP, Oses JP, Portela LV, Souza DO, Vissoci JR, Luz VF, Trintoni LM, Nielsen KC, Carmona MJ. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction-A Phase III Double Blind, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0152308. doi: 10.1371/journal.pone.0152308. eCollection 2016.
PubMed 27152422
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia
- ClinicalTrials.gov ID
- NCT01332812
- Acronym / sponsor ID
- Maria J.C. Carmona
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Dexamethasone, Postoperative cognitive dysfunction, General Anesthesia, neuropsychological tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Duke University
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Apr 2011 (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.
This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.
Detailed description
Postoperative cognitive dysfunction is related with the use of opioids in the postoperative period, lack of physical activity, fatigue, postoperative pain and quality of life. The use of corticosteroids preoperatively reduces postoperative pain, fatigue, nausea and vomiting in the postoperative period and is frequently used as an adjuvant in anesthesia. This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone, POCD, psycological tests | Experimental | Drug: DexamethasoneSubjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered. Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery. |
| Control, POCD, psycological tests | Sham comparator | Other: control groupSubjects will be randomly assigned in two groups: For the Dexamethasone group, 8mg of dexamethasone will be administered intravenously before the induction of general anesthesia. For Control Group, no Dexamethasone will be administered. Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 60 years,
- underwent surgery for inguinal hernia repair, Nissen procedure, cholecystectomy or other surgeries midsize under general anesthesia and hospital stay expected within 72 hours.
Key exclusion criteria (4 listed)
- age less than 60 years,
- history of brain disease or dementia, other psychiatric disorders that affect cognition,
- lack of proficiency in Portuguese,
- use of corticosteroids or opioid preoperatively.
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 |
|---|---|---|
| DexamethasoneAlso: The Dexamethasone and Index Bispectrala dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia | Drug | Dexamethasone, POCD, psycological tests |
| control groupAlso: Index Bispectral and not received the DesamethasoneGeneral anesthesia, without additional interventions | Other | Control, POCD, psycological tests |
Primary outcome
Score in neuropsycological tests.
Time frame: 6 months.
Tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive skills and recall, including processing speed. This assessment will be applied before surgery, and 3, 7, 21, 90 and 180 days after surgery.
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 10 Sep 2015.
- Derived from this study: PubMed 27152422Valentin LS, Pereira VF, Pietrobon RS, Schmidt AP, Oses JP, Portela LV, Souza DO, Vissoci JR, Luz VF, Trintoni LM, Nielsen KC, Carmona MJ. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction-A Phase III Double Blind, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0152308. doi: 10.1371/journal.pone.0152308. eCollection 2016.
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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.
Maria José C Carmona, M.D. principal investigator
Faculty of Medicine of the University of Sao Paulo
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 Dexamethasone in people with Postoperative Cognitive Dysfunction, run by University of Sao Paulo 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 2 inclusion and 4 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 10 Sep 2015. 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?
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?
Score in neuropsycological tests. (time frame: 6 months.). 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 NCT01332812, which also lists 1 linked publication.
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 10 Sep 2015.