Undergoing General AnaesthesiaNCT04215263
Risk Factors of POCD in General Anesthesia Patients Underwent Noncardiac and Non Neurological Procedures.
An observational study of Undergoing General Anaesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The study was a prospective cohort study to assess the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Undergoing General Anaesthesia
- What is being tested?
- Questionaire
- How many people
- 109 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2019to 5 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia
Who may be able to join
- geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia
- patient can do reading and writing
- patient can speak in Bahasa
- signing informed consent
Who cannot join
- patient with cognitive impairment or psychiatric disorder such as delirium, amnesia, anxiety disorder, or depression.
- patient under psychotropic drugs or narcotics.
- patient with history of brain tumor, head injury or motoric disturbance and disability that can disturbed neurocognitive test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors of Post Operative Cognitive Dysfunction (POCD) in General Anesthesia Patients Underwent Noncardiac and Non Neurological Procedures.
The study was a prospective cohort study to assess the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery.
Read the detailed description
The study was a prospective cohort study, assessing the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery. The study used cognitive tests such as RAVLT, TMT, and Digit span tests. POCD definition is reduction in postoperative cognitive function by as much as 20% at a minimum of 2 cognitive tests.
- Conditions
- Undergoing General Anaesthesia
- Being tested
- Questionaire
- Keywords
- postoperative cognitive dysfunction, geriatrics, general anaesthesia
- 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.
QuestionaireOther
Patient was assessed using mini international neuropsychiatric interview
| Study group | Role | What they receive |
|---|---|---|
| Geriatric patient underwent general anesthesia procedure | geriatric patients (≥60 years) ware assessed for cognitive impairment after general anesthesia for non-neurologic noncardiac surgery. Receives: Other: Questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini International Neuropsychiatric Interview
Score was assessed using 6 forms
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 May 2019
- Primary completion5 Jul 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Undergoing General AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aries Perdana, Universitas Indonesia
- Investigators
- Aries Perdana, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215263
- Sponsor's protocol ID
- IndonesiaUAnes 044
- Status last verified
- Feb 2020
- First submitted
- 30 Dec 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
BEDFORD PD. Adverse cerebral effects of anaesthesia on old people. Lancet. 1955 Aug 6;269(6884):259-63. doi: 10.1016/s0140-6736(55)92689-1. No abstract available.
PubMed 13243706Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493.
PubMed 24303859Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
PubMed 24622758Canet J, Raeder J, Rasmussen LS, Enlund M, Kuipers HM, Hanning CD, Jolles J, Korttila K, Siersma VD, Dodds C, Abildstrom H, Sneyd JR, Vila P, Johnson T, Munoz Corsini L, Silverstein JH, Nielsen IK, Moller JT; ISPOCD2 investigators. Cognitive dysfunction after minor surgery in the elderly. Acta Anaesthesiol Scand. 2003 Nov;47(10):1204-10. doi: 10.1046/j.1399-6576.2003.00238.x.
PubMed 14616316van Harten AE, Scheeren TW, Absalom AR. A review of postoperative cognitive dysfunction and neuroinflammation associated with cardiac surgery and anaesthesia. Anaesthesia. 2012 Mar;67(3):280-93. doi: 10.1111/j.1365-2044.2011.07008.x.
PubMed 22321085
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Post Operative Cognitive Dysfunction (POCD) in General Anesthesia Patients Underwent Noncardiac and Non Neurological Procedures.
- ClinicalTrials.gov ID
- NCT04215263
- Acronym / sponsor ID
- IndonesiaUAnes 044
- Conditions
- Undergoing General Anaesthesia
- Keywords
- postoperative cognitive dysfunction, geriatrics, general anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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 study was a prospective cohort study to assess the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery.
Detailed description
The study was a prospective cohort study, assessing the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery. The study used cognitive tests such as RAVLT, TMT, and Digit span tests. POCD definition is reduction in postoperative cognitive function by as much as 20% at a minimum of 2 cognitive tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric patient underwent general anesthesia procedure | – | Other: Questionairegeriatric patients (≥60 years) ware assessed for cognitive impairment after general anesthesia for non-neurologic noncardiac surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia
Key inclusion criteria (4 listed)
- geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia
- patient can do reading and writing
- patient can speak in Bahasa
- signing informed consent
Key exclusion criteria (3 listed)
- patient with cognitive impairment or psychiatric disorder such as delirium, amnesia, anxiety disorder, or depression.
- patient under psychotropic drugs or narcotics.
- patient with history of brain tumor, head injury or motoric disturbance and disability that can disturbed neurocognitive test
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 |
|---|---|---|
| QuestionairePatient was assessed using mini international neuropsychiatric interview | Other | Geriatric patient underwent general anesthesia procedure |
Primary outcome
Mini International Neuropsychiatric Interview
Time frame: 7 days
Score was assessed using 6 forms
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 21 Feb 2020.
- Results publication: PubMed 13243706BEDFORD PD. Adverse cerebral effects of anaesthesia on old people. Lancet. 1955 Aug 6;269(6884):259-63. doi: 10.1016/s0140-6736(55)92689-1. No abstract available.
- Results publication: PubMed 24303859Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493.
- Results publication: PubMed 24622758Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
- Results publication: PubMed 14616316Canet J, Raeder J, Rasmussen LS, Enlund M, Kuipers HM, Hanning CD, Jolles J, Korttila K, Siersma VD, Dodds C, Abildstrom H, Sneyd JR, Vila P, Johnson T, Munoz Corsini L, Silverstein JH, Nielsen IK, Moller JT; ISPOCD2 investigators. Cognitive dysfunction after minor surgery in the elderly. Acta Anaesthesiol Scand. 2003 Nov;47(10):1204-10. doi: 10.1046/j.1399-6576.2003.00238.x.
- Results publication: PubMed 22321085van Harten AE, Scheeren TW, Absalom AR. A review of postoperative cognitive dysfunction and neuroinflammation associated with cardiac surgery and anaesthesia. Anaesthesia. 2012 Mar;67(3):280-93. doi: 10.1111/j.1365-2044.2011.07008.x.
- Individual participant dataSharing planned: No
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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.
Aries Perdana, MD principal investigator
Universitas Indonesia
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 Undergoing General Anaesthesia, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 3 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 21 Feb 2020. 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 Indonesia. 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 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?
Mini International Neuropsychiatric Interview (time frame: 7 days). 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 NCT04215263, which also lists 5 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 21 Feb 2020.