- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06522178
Oldest-old Patients Anesthesia in Orthopedic Surgeries
July 22, 2024 updated by: mesure gul nihan ozden, Istanbul Medeniyet University
Anesthetic Techniques and Clinical Outcomes in the Oldest-old Patients Operated for Orthopedic Surgery: A Seven-year Retrospective Analysis of Data in a Third Level Hospital
Average life span, life expectancy, and the number of older people, aged 65 years and over, have increased during the last decades.
As life expectancy increased, the rate of emergency and elective surgical interventions has also increased in the older age group.
Although good health is required to reach an advanced age, over time, organ functions may deteriorate, and some challenges may develop that will negatively affect the balance of homeostasis.
Stress, such as trauma or surgery, can cause deterioration in organ functions or aggravation of impaired functions.
The risk of developing undesirable events is higher, due to the diminished reserve and function, during anesthesia applied to these patients.
There is a limited number of studies in the literature about the relation between the anesthesia technique and morbidity and mortality in oldest old patients operated for orthopedic surgery.
In this study, we aimed to analyze the data of the oldest-old patients operated on for orthopedic surgery between 2016-2022, retrospectively, and to investigate the relationship between anesthesia technique and adverse effects including morbidity and mortality.
Study Overview
Study Type
Observational
Enrollment (Actual)
1356
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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İ̇stanbul, Turkey, 34730
- Istanbul Medeniyet University
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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
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
A total of 1356 oldest-old patients underwent orthopedic surgery between January 02 2016 and December 31 2022 in our hospital.
Description
Inclusion Criteria:
- Aged 80 years and above
- Underwent orthopedic surgery
Exclusion Criteria:
- Those who had the operation with local anesthesia
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 |
|---|---|
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Group 1
Group I patients contained those who were between 80 (included) and 89 (included) years of age.
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Patients were divided into two groups according to their ages.
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Group 2
Those who were 90 years of age and above were included in Group II
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Patients were divided into two groups according to their ages.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mortality
Time Frame: one month after operation
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postoperative mortality
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one month after operation
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Anesthesia Techniques
Time Frame: up to 6 hours
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Data were also analyzed and compared with groups and between groups according to the applied anesthesia technique (general anesthesia versus regional anesthesia).
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up to 6 hours
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Type of operation
Time Frame: up to 6 hours
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Orthopedic surgery type
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up to 6 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence and type of comorbidities
Time Frame: 6 month period before operation
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Hypertension, dementia, asthma, COPD (Chronic obstructive pulmonary disease), CHF (Chronic Heart Failure), CAD (Coronary artery disease), DM (Diabetes mellitus), valvular heart disease, history of pulmonary emboli, electrolyte imbalance, presence of cancer, renal diseases, history of cerebrovascular disease, endocrine diseases, neurologic diseases, other chronic diseases
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6 month period before operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 3, 2016
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
July 22, 2024
First Submitted That Met QC Criteria
July 22, 2024
First Posted (Actual)
July 26, 2024
Study Record Updates
Last Update Posted (Actual)
July 26, 2024
Last Update Submitted That Met QC Criteria
July 22, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Oldest-old Patient Anesthesia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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