AnesthesiaNCT06522178
Oldest-old Patients Anesthesia in Orthopedic Surgeries
An observational study of Anesthesia, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 80 to 100 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Patient' ages
- How many people
- 1,356 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2016to 1 Jan 2024
- 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 80 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: A total of 1356 oldest-old patients underwent orthopedic surgery between January 02 2016 and December 31 2022 in our hospital.
Who may be able to join
- Aged 80 years and above
- Underwent orthopedic surgery
Who cannot join
- Those who had the operation with local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia
- Being tested
- Patient' ages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient' agesOther
Patients were divided into two groups according to their ages.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group I patients contained those who were between 80 (included) and 89 (included) years of age. Receives: Other: Patient' ages | |
| Group 2 | Those who were 90 years of age and above were included in Group II Receives: Other: Patient' ages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
postoperative mortality
Measured: one month after operation
Anesthesia Techniques
Data were also analyzed and compared with groups and between groups according to the applied anesthesia technique (general anesthesia versus regional anesthesia).
Measured: up to 6 hours
Type of operation
Orthopedic surgery type
Measured: up to 6 hours
Secondary outcomes (1)
Presence and type of comorbidities
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
Measured: 6 month period before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start3 Jan 2016
- Primary completion31 Dec 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mesure gul nihan ozden, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522178
- Sponsor's protocol ID
- Oldest-old Patient Anesthesia
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06522178
- Acronym / sponsor ID
- Oldest-old Patient Anesthesia
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,356 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 26 Jul 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Patient' agesGroup I patients contained those who were between 80 (included) and 89 (included) years of age. |
| Group 2 | – | Other: Patient' agesThose who were 90 years of age and above were included in Group II |
Who may qualify
- Ages
- 80 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A total of 1356 oldest-old patients underwent orthopedic surgery between January 02 2016 and December 31 2022 in our hospital.
Key inclusion criteria (2 listed)
- Aged 80 years and above
- Underwent orthopedic surgery
Key exclusion criteria (1 listed)
- Those who had the operation with local anesthesia
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 |
|---|---|---|
| Patient' agesPatients were divided into two groups according to their ages. | Other | Group 1, Group 2 |
Primary outcome
Mortality
Time frame: one month after operation
postoperative mortality
Anesthesia Techniques
Time frame: up to 6 hours
Data were also analyzed and compared with groups and between groups according to the applied anesthesia technique (general anesthesia versus regional anesthesia).
Type of operation
Time frame: up to 6 hours
Orthopedic surgery type
1 secondary outcome
Presence and type of comorbidities
Time frame: 6 month period before operation
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 26 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Anesthesia, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 2 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 26 Jul 2024. 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 Turkey (Türkiye). 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?
Mortality (time frame: one month after operation). The study lists 3 primary outcomes in all. 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 26 Jul 2024.