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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT03290599
Study groupRoleWhat they receive
No Post operative cognitive dysfunctionPatients 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 dysfunctionPatients 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.

  1. 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.

  1. First posted25 Sep 2017
  2. Study start1 Nov 2013
  3. Primary completion30 Sep 2014
  4. Study completion30 Sep 2014

Resources

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)
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

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.

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