FrailtyNCT06757439
Frailty and Spinal Anesthesia-Induced Hypotension in Elderly
An observational study of Frailty and Spinal Anesthesia, run by Selcuk University.
Trial summary
60 patients aged 65 and older with ASA I-III physical status undergoing elective surgery under spinal anesthesia will be included in the study. Patients with cardiac arrhythmia, severe heart failure, cerebrovascular disease, or contraindications to neuraxial anesthesia will be excluded. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Spinal Anesthesia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 20 Mar 2025
- How long will I take part?
- 1 Day
- 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: Male and female patients aged 65 and over
Who may be able to join
- 65 and older
- ASA I-III physical status
- Undergoing elective surgery under spinal anesthesia
Who cannot join
- Patients with cardiac arrhythmia
- Patients with severe heart failure
- Patients with cerebrovascular disease
- Contraindications to neuraxial anesthesia
About this study
Official title: Effect of Frailty on Spinal Anesthesia-induced Hypotension in Geriatric Patients
60 patients aged 65 and older with ASA I-III physical status undergoing elective surgery under spinal anesthesia will be included in the study.
Patients with cardiac arrhythmia, severe heart failure, cerebrovascular disease, or contraindications to neuraxial anesthesia will be excluded. Frailty assessments will be performed using the Clinical Frailty Scale (CFS) version 2.0 by anesthesiologists in preoperative clinics or wards. Participants will be categorized into frail (CFS Level ≥4, Group I) and non-frail (CFS Level ≤3, Group II) groups.
Read more
Prior to spinal anesthesia, 8 mL/kg of crystalloids will be administered. Baseline preoperative mean arterial blood pressure (MABP) and heart rate (HR) will be recorded as the average of three measurements in the supine position.
During the study, MABP and HR will be monitored every 2 minutes for the first 20 minutes post-spinal anesthesia, then every 5 minutes until surgery ends. Hypotension (MABP <80% of baseline) will be treated with 5 mg intravenous ephedrine, while bradycardia (HR <50 beats/min) will be treated with 0.5 mg intravenous atropine.
- Conditions
- Frailty, Spinal Anesthesia
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail | CFS Level ≥4 | |
| Non-frail | CFS Level ≤3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hypotension
Hypotension, defined as MABP below 80% of baseline values
Measured: Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.
Secondary outcomes (3)
Rate of Bradycardia
Bradycardia defined as HR <50 beats/min
Measured: Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.
Ephedrine usage
Necessary use of ephedrine (mg) for patients who develop hypotension
Measured: During the procedure
Rate of Nausea and vomiting
Nausea and vomiting Visual analogue scale
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet SARGIN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757439
- Sponsor's protocol ID
- 2024-12-1
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 3 Jan 2025
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Frailty on Spinal Anesthesia-induced Hypotension in Geriatric Patients
- ClinicalTrials.gov ID
- NCT06757439
- Acronym / sponsor ID
- 2024-12-1
- Conditions
- Frailty, Spinal Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 3 Jan 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.
60 patients aged 65 and older with ASA I-III physical status undergoing elective surgery under spinal anesthesia will be included in the study.
Patients with cardiac arrhythmia, severe heart failure, cerebrovascular disease, or contraindications to neuraxial anesthesia will be excluded. Frailty assessments will be performed using the Clinical Frailty Scale (CFS) version 2.0 by anesthesiologists in preoperative clinics or wards. Participants will be categorized into frail (CFS Level ≥4, Group I) and non-frail (CFS Level ≤3, Group II) groups.
Prior to spinal anesthesia, 8 mL/kg of crystalloids will be administered. Baseline preoperative mean arterial blood pressure (MABP) and heart rate (HR) will be recorded as the average of three measurements in the supine position.
During the study, MABP and HR will be monitored every 2 minutes for the first 20 minutes post-spinal anesthesia, then every 5 minutes until surgery ends. Hypotension (MABP <80% of baseline) will be treated with 5 mg intravenous ephedrine, while bradycardia (HR <50 beats/min) will be treated with 0.5 mg intravenous atropine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail | – | –CFS Level ≥4 |
| Non-frail | – | –CFS Level ≤3 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Male and female patients aged 65 and over
Key inclusion criteria (3 listed)
- 65 and older
- ASA I-III physical status
- Undergoing elective surgery under spinal anesthesia
Key exclusion criteria (4 listed)
- Patients with cardiac arrhythmia
- Patients with severe heart failure
- Patients with cerebrovascular disease
- Contraindications to neuraxial anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Hypotension
Time frame: Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.
Hypotension, defined as MABP below 80% of baseline values
3 secondary outcomes
Rate of Bradycardia
Time frame: Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.
Ephedrine usage
Time frame: During the procedure
Rate of Nausea and vomiting
Time frame: up to 24 hours
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 3 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Spinal Anesthesia, run by Selcuk University.
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 4 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 3 Jan 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?
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?
Rate of Hypotension (time frame: Preoperative baseline, every 2 minutes for the first 20 minutes, and then at 5-minute intervals until the completion of the surgery.). 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 3 Jan 2025.