NCT05058378

Brief Summary

Investigation of the correlation between the success of obtaining unilateral spinal anesthesia and the measurement of perfusion index (pi).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 17, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 17, 2021

Last Update Submit

September 17, 2021

Conditions

Keywords

spinal anesthesia, perfusion index

Outcome Measures

Primary Outcomes (1)

  • perfusion index is my indicator of unilateral spinal anesthesia

    Pulse oximetry perfusion index (PI) was used in our study to indicate vasodilation associated with sympathectomy. We will examine whether the success of unilateral anesthesia in the spinal anesthesia performed in our hospital correlates with the increase of the perfusion index value measured with the finger probe, except for patient-based methods, and whether the perfusion index shows more objectively the block success than other patient-based traditional methods.

    1 month

Interventions

Clip will be attached to the patient's toe for perfusion index measurement

Eligibility Criteria

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

Male and female patients between the ages of 18-65

You may qualify if:

  • Patients who will undergo lower abdominal, urogenital, lower extremity surgery
  • Patients with ASA 1-2
  • Patients aged 18-65

You may not qualify if:

  • Patients with ASA3-4
  • Those with peripheral vascular disease
  • Patients with a history of by-pass
  • Patients with aortic stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman University

Adıyaman, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 27, 2021

Study Start

September 20, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

I do not plan to make individual participant data available to other researchers

Locations