- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058378
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
Recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Anticipated)
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
- Name: öznur uludağ
- Phone Number: +904162231690 05052309730
- Email: uludagoznur@gmail.com
Study Locations
-
-
-
Adıyaman, Turkey
- Recruiting
- Adıyaman University
-
Contact:
- öznur uludağ
- Phone Number: +9 04162231690 05052309730
- Email: uludagoznur@gmail.com
-
-
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
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:
- Patients who will undergo lower abdominal, urogenital, lower extremity surgery
- Patients with ASA 1-2
- Patients aged 18-65
Exclusion Criteria:
- Patients with ASA3-4
- Those with peripheral vascular disease
- Patients with a history of by-pass
- 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
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
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)
September 20, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
September 17, 2021
First Submitted That Met QC Criteria
September 17, 2021
First Posted (Actual)
September 27, 2021
Study Record Updates
Last Update Posted (Actual)
September 27, 2021
Last Update Submitted That Met QC Criteria
September 17, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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