Post Operative Cognitive DysfunctionNCT03290599
Effect of Preoperative Hospitalization Duration on Post-operative Cognitive Dysfunction
An observational study of Post Operative Cognitive Dysfunction, run by Burcu Ozalp Horsanali.
Trial summary
Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which develop following surgery and anesthesia administration that can last up to weeks or even months after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Cognitive Dysfunction
- What is being tested?
- Mini Mental and Modified Mini Mental Test
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 30 Sep 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent total hip replacement surgery over 18 aged
Who may be able to join
- Patients who were planned to undergo total hip replacement surgery without cement over 18 years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were included in the study.
Who cannot join
- Patients younger than 18, who did not speak Turkish, with known cancer history, previous steroid treatment, SVO history in last 6 months, with central nervous system diseases (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia, Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6 months, uncooperative patients, patients with substance abuse problems, patients with severe organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who required ICU following surgery, patients where regional anesthesia was contraindicated (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational site) were excluded from the study.
About this study
Official title: Effect of Preoperative Hospitalization Duration on Post-operative Cognitive Dysfunction in Patients Who Underwent Hip Surgery Under Regional Anesthesia
Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which develop following surgery and anesthesia administration that can last up to weeks or even months after surgery. In this study, our main objective was to investigate the effect of preoperative hospitalisation period on early post operative cognitive dysfunction development and its risk factors in patients who underwent total hip replacement surgery for hip fractures under regional anesthesia.
Read the detailed description
The study evaluated Mini Mental Test scores of patients who received total hip replacement surgery in Izmir Bozyaka Training and Research Hospital from November 2013 to September 2014. In the assessment, Mini Mental Test (MMT) was used for literate and Modified Mini Mental Test (MMMT) was used for illiterate patients. Test scores were obtained on the initial admission day (MMT1), 24 hours prior to surgery (MMT2) and 24 hours after the surgery (MMT3). A drop of 4 points or more between each test was defined as significant cognitive dysfunction development. Patients who did not have any change or a change less than 4 points between MMT1 and MMT3 were grouped as "no cognitive dysfunction" (Group 1) and patients with a difference more than 4 points between MMT1 and MMT3 were grouped as "cognitive dysfunction" (Group 2). All analyses were performed using those 2 patient groups.
Patients who were planned to undergo total hip replacement surgery without cement over 18 years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were included in the study.
Patients younger than 18, who did not speak Turkish, with known cancer history, previous steroid treatment, SVO history in last 6 months, with central nervous system diseases (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia, Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6 months, uncooperative patients, patients with substance abuse problems, patients with severe organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who required ICU following surgery, patients where regional anesthesia was contraindicated (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational site) were excluded from the study.
No premedication was done on patients during preoperative period. Hydration during preoperative period was done by IV 0.9% NaCl aqueous solution with a fasting period of 6-10 hours prior to surgery.
In our study, combined spinal-epidural anesthesia was used for anesthesia for all the patients. Surgical intervention was allowed on the patients with sensory block on T8 dermatome levels. Patients also received 0.5 mg IV bolus midazolam with Ramsey Sedation Scale 3.
During anesthesia, systolic blood pressure decreases more than 20% compared to preoperative period was defined as hypotension. 5 mg IV Ephedrine was administered to the patients when their arterial blood pressure levels stayed 50mmHg and below despite fluid replacement. Bradycardia was defined as pulses below 40 bpm and was treated with 0.5 mg IV atropine.
Postoperative pain management was planned according to Visual Analogue Scale (VAS). In patients with VAS score 3 and above, 10 ml isobaric bupivacaine 0.125% was administered through epidural catheter. No additional medication (opiates or NSAIDs) were used for analgesia.
Demographics, education levels, employment status, operation indications, ASA scores, comorbid diseases and tobacco use of all patients were questioned and recorded. Scores of MMT or MMMT of patients on their initial admission, 24 hours prior to surgery and 24 hours after surgery and its parameters were all recorded and grouped.
The period from the initial admission to the surgery date was calculated and recorded. Patients' hemoglobin, hematocrit, serum electrolyte levels on their admission, preoperative and postoperative periods were recorded.
Finally, anesthesia duration, surgery duration, administered midazolam, atropine and ephedrine doses, crystalloid, colloid, blood and blood products used during surgery and total blood loss volume were all recorded.
- Conditions
- Post Operative Cognitive Dysfunction
- Being tested
- Mini Mental and Modified Mini Mental Test
- Keywords
- Cognitive dysfunction, Hip Surgery, Mini mental Test,, Preoperative Hospitalisation, Spinal Anesthesia
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Mental and Modified Mini Mental TestOther
Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients
| Study group | Role | What they receive |
|---|---|---|
| No Post operative cognitive dysfunction | Patients who did not have any change or a change less than 4 points between MMT1 and MMT3 Receives: Other: Mini Mental and Modified Mini Mental Test | |
| Post operative cognitive dysfunction | Patients with a difference more than 4 points between MMT1 and MMT3 Receives: Other: Mini Mental and Modified Mini Mental Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Cognitive Dysfunction
Mini mental test
Measured: change of Mini mental test score from hospitalisation time to post operative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Nov 2013
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burcu Ozalp Horsanali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burcu Ozalp Horsanali, Kackar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290599
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2017
- First submitted
- 17 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Hospitalization Duration on Post-operative Cognitive Dysfunction in Patients Who Underwent Hip Surgery Under Regional Anesthesia
- ClinicalTrials.gov ID
- NCT03290599
- Acronym / sponsor ID
- 1
- Conditions
- Post Operative Cognitive Dysfunction
- Keywords
- Cognitive dysfunction, Hip Surgery, Mini mental Test,, Preoperative Hospitalisation, Spinal Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Burcu Ozalp HorsanaliUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 25 Sep 2017 (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.
Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which develop following surgery and anesthesia administration that can last up to weeks or even months after surgery. In this study, our main objective was to investigate the effect of preoperative hospitalisation period on early post operative cognitive dysfunction development and its risk factors in patients who underwent total hip replacement surgery for hip fractures under regional anesthesia.
Detailed description
The study evaluated Mini Mental Test scores of patients who received total hip replacement surgery in Izmir Bozyaka Training and Research Hospital from November 2013 to September 2014. In the assessment, Mini Mental Test (MMT) was used for literate and Modified Mini Mental Test (MMMT) was used for illiterate patients. Test scores were obtained on the initial admission day (MMT1), 24 hours prior to surgery (MMT2) and 24 hours after the surgery (MMT3). A drop of 4 points or more between each test was defined as significant cognitive dysfunction development. Patients who did not have any change or a change less than 4 points between MMT1 and MMT3 were grouped as "no cognitive dysfunction" (Group 1) and patients with a difference more than 4 points between MMT1 and MMT3 were grouped as "cognitive dysfunction" (Group 2). All analyses were performed using those 2 patient groups.
Patients who were planned to undergo total hip replacement surgery without cement over 18 years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were included in the study.
Patients younger than 18, who did not speak Turkish, with known cancer history, previous steroid treatment, SVO history in last 6 months, with central nervous system diseases (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia, Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6 months, uncooperative patients, patients with substance abuse problems, patients with severe organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who required ICU following surgery, patients where regional anesthesia was contraindicated (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational site) were excluded from the study.
No premedication was done on patients during preoperative period. Hydration during preoperative period was done by IV 0.9% NaCl aqueous solution with a fasting period of 6-10 hours prior to surgery.
In our study, combined spinal-epidural anesthesia was used for anesthesia for all the patients. Surgical intervention was allowed on the patients with sensory block on T8 dermatome levels. Patients also received 0.5 mg IV bolus midazolam with Ramsey Sedation Scale 3.
During anesthesia, systolic blood pressure decreases more than 20% compared to preoperative period was defined as hypotension. 5 mg IV Ephedrine was administered to the patients when their arterial blood pressure levels stayed 50mmHg and below despite fluid replacement. Bradycardia was defined as pulses below 40 bpm and was treated with 0.5 mg IV atropine.
Postoperative pain management was planned according to Visual Analogue Scale (VAS). In patients with VAS score 3 and above, 10 ml isobaric bupivacaine 0.125% was administered through epidural catheter. No additional medication (opiates or NSAIDs) were used for analgesia.
Demographics, education levels, employment status, operation indications, ASA scores, comorbid diseases and tobacco use of all patients were questioned and recorded. Scores of MMT or MMMT of patients on their initial admission, 24 hours prior to surgery and 24 hours after surgery and its parameters were all recorded and grouped.
The period from the initial admission to the surgery date was calculated and recorded. Patients' hemoglobin, hematocrit, serum electrolyte levels on their admission, preoperative and postoperative periods were recorded.
Finally, anesthesia duration, surgery duration, administered midazolam, atropine and ephedrine doses, crystalloid, colloid, blood and blood products used during surgery and total blood loss volume were all recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Post operative cognitive dysfunction | – | Other: Mini Mental and Modified Mini Mental TestPatients who did not have any change or a change less than 4 points between MMT1 and MMT3 |
| Post operative cognitive dysfunction | – | Other: Mini Mental and Modified Mini Mental TestPatients with a difference more than 4 points between MMT1 and MMT3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent total hip replacement surgery over 18 aged
Key inclusion criteria (1 listed)
- Patients who were planned to undergo total hip replacement surgery without cement over 18 years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were included in the study.
Key exclusion criteria (1 listed)
- Patients younger than 18, who did not speak Turkish, with known cancer history, previous steroid treatment, SVO history in last 6 months, with central nervous system diseases (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia, Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6 months, uncooperative patients, patients with substance abuse problems, patients with severe organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who required ICU following surgery, patients where regional anesthesia was contraindicated (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational site) were excluded from the study.
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 |
|---|---|---|
| Mini Mental and Modified Mini Mental TestMini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients | Other | No Post operative cognitive dysfunction, Post operative cognitive dysfunction |
Primary outcome
Post operative Cognitive Dysfunction
Time frame: change of Mini mental test score from hospitalisation time to post operative 24th hour
Mini mental test
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 Sep 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Cognitive Dysfunction, run by Burcu Ozalp Horsanali.
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 1 inclusion and 1 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 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Post operative Cognitive Dysfunction (time frame: change of Mini mental test score from hospitalisation time to post operative 24th hour). 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 Sep 2017.