Correlation Between Spinal Anesthesia and Perfusion Index

September 17, 2021 updated by: MEHMET DURAN, Adiyaman University

Investigation of the Correlation Between the Success of Obtaining Unilateral Spinal Anesthesia and the Measurement of Perfusion Index (pi).

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Target sites for spinal anesthetics are spinal nerve roots and spinal cord. Differences in the anatomy of the nerve roots may explain the variability that occurs during spinal anesthesia. Spinal anesthesia is the cessation of nerve conduction for a while by injection of local anesthetic drug into the cerebrospinal fluid. It is one of the most effective and oldest regional anesthesia techniques. Unilateral spinal anesthesia, on the other hand, aims to limit the distribution of the spinal block to the operated side for all operations involving only one lower extremity. Reducing the dose of local anesthetic, pencil-point needles, injection speed, lateral decubitus position and non-isobaric anesthetic solution are the main factors in the formation of a unilateral spinal block. It requires slightly longer preparation time compared to standard spinal anesthesia, but provides fewer hemodynamic side effects with higher cardiovascular stability, increased postoperative autonomy and better patient acceptance. Perfusion index (PI) is a numerical value showing the ratio between pulsatile and nonpulsatile blood flow. PI works by measuring changes in finger peripheral perfusion via pulse oximetry. If the procedure is successful in patients undergoing spinal anesthesia, vasodilation occurs in the lower extremities due to sympathetic nerve blockage and perfusion increases. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Adıyaman, Turkey
        • Recruiting
        • Adıyaman University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and female patients between the ages of 18-65

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with ASA3-4
  2. Those with peripheral vascular disease
  3. Patients with a history of by-pass
  4. Patients with aortic stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
perfusion index is my indicator of unilateral spinal anesthesia
Time Frame: 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adiyaman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • date:22/12/2020 ID:2020/11-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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