Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia
1 other identifier
observational
120
1 country
1
Brief Summary
It is aimed to investigate whether the perfusion index (PI) can predict hypotension after spinal anesthesia in elderly patients as much as in non-elderly patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2024
CompletedFirst Posted
Study publicly available on registry
May 23, 2024
CompletedStudy Start
First participant enrolled
May 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedOctober 22, 2024
October 1, 2024
3 months
May 19, 2024
October 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perfusion index age difference
Determine a threshold for baseline PI value using logistic regression analysis to predict hypotension after spinal anesthesia
1 hours
Secondary Outcomes (12)
Perfusion index cut-off point
1 hours
Systolic blood pressure
1 hours
Diastolic blood pressure
1 hours
Mean arterial pressure
1 hours
Hearth Rate
1 hours
- +7 more secondary outcomes
Study Arms (2)
group E (age > 65 years)
Patients aged 65 years and older
group N (age < 65 years)
Patients aged 18 to 65 years
Interventions
Perfusion index determination using non-invasive pulse oximetry
Eligibility Criteria
patients admitted to ankara city hospital for lower extremity surgery in supine position
You may qualify if:
- American Society of Anesthesiologists (ASA) I-II-III physical status
- patients planned for effective lower extremity surgery in the supine position
- age \>18 years
You may not qualify if:
- Known cardiac abnormalities (left ventricular ejection fraction \<50% or decompensated heart failure, heart block, arrhythmia)
- uncontrolled hypertension
- hyperthyroidism
- monoamine oxidase inhibitor use
- chronic beta-blocker or digoxin therapy
- severe arrhythmia
- peripheral arterial disease
- history of glaucoma
- hepatic cell failure
- renal failure
- local anesthetic allergy
- contraindications for spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Bilkent City Hospital
Ankara, Ankara, Çankaya,, 06800, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- anesthesiology and reanimation associate professor
Study Record Dates
First Submitted
May 19, 2024
First Posted
May 23, 2024
Study Start
May 25, 2024
Primary Completion
August 15, 2024
Study Completion
October 1, 2024
Last Updated
October 22, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share