Cognitive DysfunctionNCT00700674
Effect of Usage of Electroencephalogram (EEG) Entropy on the Incidence of Postoperative Cognitive Dysfunction in Geriatric Patients
An observational study of Cognitive Dysfunction, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly patients after general anesthesia. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cognitive Dysfunction
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2008to Nov 2011
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 Elderly patient, ASA 1-2
Who may be able to join
- ASA physical status I-II.
- scheduled for retinal surgery expected to take 2-3 hours under general anesthesia.
- orotracheal intubation.
Who cannot join
- history of cardiac, pulmonary, liver or renal disease.
- significant obesity (body mass index >30.
- Long-term user of central nervous system activator drugs, benzodiazepines and/or opiates.
- dementia, brain atrophy and other neurological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Ese of EEG Entropy as Intra-operative Monitor Improves Postoperative Cognitive Dysfunction
To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly patients after general anesthesia.
- Conditions
- Cognitive Dysfunction
- Keywords
- EEG entropy, Elderly, Decreases, POCD, Use of EEG entropy, Geriatric
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Entropy group | |
| 2 | Control |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Progress report requested by Dr. Abboud decided to close it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khaled Eye Specialist Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Waleed Riad, MD,AB,SB, Principal investigator, King Khaled Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700674
- Sponsor's protocol ID
- RP 0729
- Status last verified
- Feb 2010
- First submitted
- 18 Jun 2008
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Ese of EEG Entropy as Intra-operative Monitor Improves Postoperative Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT00700674
- Acronym / sponsor ID
- RP 0729
- Conditions
- Cognitive Dysfunction
- Keywords
- EEG entropy, Elderly, Decreases, POCD, Use of EEG entropy, Geriatric
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Progress report requested by Dr. Abboud decided to close it.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Khaled Eye Specialist HospitalOther government
- Study start
- Jan 2008 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 19 Jun 2008 (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.
To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly patients after general anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Entropy group |
| 2 | – | –Control |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 Elderly patient, ASA 1-2
Key inclusion criteria (3 listed)
- ASA physical status I-II.
- scheduled for retinal surgery expected to take 2-3 hours under general anesthesia.
- orotracheal intubation.
Key exclusion criteria (4 listed)
- history of cardiac, pulmonary, liver or renal disease.
- significant obesity (body mass index >30.
- Long-term user of central nervous system activator drugs, benzodiazepines and/or opiates.
- dementia, brain atrophy and other neurological disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Progress report requested by Dr. Abboud decided to close it.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
Related trials for Cognitive Dysfunction
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
Waleed Riad, MD,AB,SB principal investigator
King Khaled Eye Specialist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
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 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: stopped early, as of the sponsor's last update on 21 Oct 2021. 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 Saudi Arabia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Progress report requested by Dr. Abboud decided to close it.). 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.
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 21 Oct 2021.