NCT06427382

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 25, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

May 19, 2024

Last Update Submit

October 20, 2024

Conditions

Keywords

spinal anesthesiaperfusion indexorthopedic surgery

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

Device: Perfusion index

group N (age < 65 years)

Patients aged 18 to 65 years

Device: Perfusion index

Interventions

Perfusion index determination using non-invasive pulse oximetry

group E (age > 65 years)group N (age < 65 years)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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)

Location

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

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

Locations