Frail Elderly SyndromeNCT07191769
The Importance of Anesthesia Method in Fragile Patients
An observational study of Frail Elderly Syndrome, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
Trial summary
The aim of this study is to comparatively evaluate the effects of different anaesthesia methods (spinal anaesthesia and general anaesthesia) administered to frail elderly patients scheduled for transurethral surgery (e.g. TUR-Prostate or TUR-Bladder) on postoperative morbidity and mortality rates. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- general anaesthesia and regional anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years and older who are scheduled for transurethral surgery (such as TUR-P or TUR-M), meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in the study. A validated frailty score (FRAIL Survey) will be used for frailty assessment.
Who may be able to join
- Elderly patients aged 65 and over
- ASA (American Society of Anaesthesiologists) physical condition classification I-III patients
- meeting the criteria for frailty
Who cannot join
- Non-elective emergency surgeries
- Patients under 65 years of age
- Patients classified as ASA Class IV
- Patients unable to provide informed consent due to cognitive impairment
- Patients who have previously undergone major neurological or cardiac surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of the Selected Anaesthesia Method on Morbidity and Mortality in Frail Patients Scheduled for Transurethral Surgery
The aim of this study is to comparatively evaluate the effects of different anaesthesia methods (spinal anaesthesia and general anaesthesia) administered to frail elderly patients scheduled for transurethral surgery (e.g. TUR-Prostate or TUR-Bladder) on postoperative morbidity and mortality rates.
Read the detailed description
When planning transurethral surgery in frail patients, optimising the anaesthesia method is critical in minimising perioperative risks. In a 2021 study by Darwish et al. (1), 28,486 TUR-P cases were grouped according to the selected anaesthesia method. The 30-day mortality rate was 0.4% in the neuroaxial anaesthesia (spinal/epidural) group and 0.7% in the general anaesthesia group; the neuroaxial anaesthesia group showed significantly better outcomes in terms of secondary morbidity rates such as mortality and sepsis. However, there are studies in the literature supporting general anaesthesia. A study by Ayoub et al. (4) emphasised that in frail patients, similar morbidity rates can be achieved with general anaesthesia or spinal anaesthesia; spinal anaesthesia may increase the risk of hypotension and bradycardia. Based on these studies, the selection of the appropriate anaesthesia method for transurethral procedures is of critical importance in terms of patient morbidity and mortality rates. This study aims to contribute to clinical guidelines by clarifying which type of anaesthesia is safer in this specific demographic and clinical group. Within the scope of the research, parameters such as complications associated with the anaesthesia method, length of hospital stay, readmission rate, and 30-day mortality are analysed with the aim of determining the most appropriate and safest anaesthesia method for the vulnerable patient group.
- Conditions
- Frail Elderly Syndrome
- Being tested
- general anaesthesia, regional anaesthesia
- Keywords
- frail patient, general anaesthesia, regional anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general anaesthesiaProcedure or surgery
Patients undergoing general anaesthesia
regional anaesthesiaProcedure or surgery
Patients undergoing regional anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing general anaesthesia | Patients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing general anaesthesia. Receives: Procedure: general anaesthesia | |
| Patients undergoing regional anaesthesia | Patients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing regional anaesthesia. Receives: Procedure: regional anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity
Morbidity rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.
Measured: 30-day postoperative morbidity
Postoperative mortality
Mortality rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.
Measured: 30-day postoperative mortality
Secondary outcomes (3)
intraoperative complications,
In the study, complications that develop during surgery (arrhythmia etc.), whether the surgical time differs between the two groups, and the length of hospital stay will be recorded.
Measured: perioperative period
Duration of surgery
The surgical durations of patients in both groups will be recorded in the study.
Measured: Until the end of the surgery
Length of hospital stay
The length of time the patient stays in hospital for the operation will be recorded.
Measured: first week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilek Yamac, Principal investigator, Sultan Abdülhamid Han education and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191769
- Sponsor's protocol ID
- SBU-ANESTEZİ-DMY-04
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 25 Sep 2025
- 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 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Selected Anaesthesia Method on Morbidity and Mortality in Frail Patients Scheduled for Transurethral Surgery
- ClinicalTrials.gov ID
- NCT07191769
- Acronym / sponsor ID
- SBU-ANESTEZİ-DMY-04
- Conditions
- Frail Elderly Syndrome
- Keywords
- frail patient, general anaesthesia, regional anaesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
The aim of this study is to comparatively evaluate the effects of different anaesthesia methods (spinal anaesthesia and general anaesthesia) administered to frail elderly patients scheduled for transurethral surgery (e.g. TUR-Prostate or TUR-Bladder) on postoperative morbidity and mortality rates.
Detailed description
When planning transurethral surgery in frail patients, optimising the anaesthesia method is critical in minimising perioperative risks. In a 2021 study by Darwish et al. (1), 28,486 TUR-P cases were grouped according to the selected anaesthesia method. The 30-day mortality rate was 0.4% in the neuroaxial anaesthesia (spinal/epidural) group and 0.7% in the general anaesthesia group; the neuroaxial anaesthesia group showed significantly better outcomes in terms of secondary morbidity rates such as mortality and sepsis. However, there are studies in the literature supporting general anaesthesia. A study by Ayoub et al. (4) emphasised that in frail patients, similar morbidity rates can be achieved with general anaesthesia or spinal anaesthesia; spinal anaesthesia may increase the risk of hypotension and bradycardia. Based on these studies, the selection of the appropriate anaesthesia method for transurethral procedures is of critical importance in terms of patient morbidity and mortality rates. This study aims to contribute to clinical guidelines by clarifying which type of anaesthesia is safer in this specific demographic and clinical group. Within the scope of the research, parameters such as complications associated with the anaesthesia method, length of hospital stay, readmission rate, and 30-day mortality are analysed with the aim of determining the most appropriate and safest anaesthesia method for the vulnerable patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing general anaesthesia | – | Procedure: general anaesthesiaPatients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing general anaesthesia. |
| Patients undergoing regional anaesthesia | – | Procedure: regional anaesthesiaPatients aged 65 years and older who are scheduled for transurethral surgery, meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in this group after being enrolled in the study and undergoing regional anaesthesia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older who are scheduled for transurethral surgery (such as TUR-P or TUR-M), meet frailty criteria, and have an American Society of Anesthesiologists (ASA) physical status classification of I-III will be included in the study. A validated frailty score (FRAIL Survey) will be used for frailty assessment.
Key inclusion criteria (3 listed)
- Elderly patients aged 65 and over
- ASA (American Society of Anaesthesiologists) physical condition classification I-III patients
- meeting the criteria for frailty
Key exclusion criteria (5 listed)
- Non-elective emergency surgeries
- Patients under 65 years of age
- Patients classified as ASA Class IV
- Patients unable to provide informed consent due to cognitive impairment
- Patients who have previously undergone major neurological or cardiac surgery
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 |
|---|---|---|
| general anaesthesiaPatients undergoing general anaesthesia | Procedure or surgery | Patients undergoing general anaesthesia |
| regional anaesthesiaPatients undergoing regional anaesthesia | Procedure or surgery | Patients undergoing regional anaesthesia |
Primary outcome
Postoperative morbidity
Time frame: 30-day postoperative morbidity
Morbidity rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.
Postoperative mortality
Time frame: 30-day postoperative mortality
Mortality rates up to the 30th day postoperatively will be recorded. Patients will be contacted by phone and the data will be recorded.
3 secondary outcomes
intraoperative complications,
Time frame: perioperative period
Duration of surgery
Time frame: Until the end of the surgery
Length of hospital stay
Time frame: first week after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- 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.
Dilek Yamac principal investigator
Sultan Abdülhamid Han education and research hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 25 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek MD Metin Yamac (05054959792, ddilekmetin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morbidity (time frame: 30-day postoperative morbidity). The study lists 2 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 25 Sep 2025.