Effect of Preoperative Hospitalization Duration on Post-operative Cognitive Dysfunction

September 20, 2017 updated by: Burcu Ozalp Horsanali

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

64

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent total hip replacement surgery over 18 aged

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Post operative cognitive dysfunction
Patients who did not have any change or a change less than 4 points between MMT1 and MMT3
Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients
Post operative cognitive dysfunction
Patients with a difference more than 4 points between MMT1 and MMT3
Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative Cognitive Dysfunction
Time Frame: change of Mini mental test score from hospitalisation time to post operative 24th hour
Mini mental test
change of Mini mental test score from hospitalisation time to post operative 24th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

September 30, 2014

Study Completion (Actual)

September 30, 2014

Study Registration Dates

First Submitted

September 17, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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