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NCT05091606

Lower and Upper Extremity Perfusion Index (PI) in Pregnant Women Under Spinal Anesthesia

Status unknown Last updated 25 October 2021
What this trial tests

trial testing Perfusion İndex in Patients with Spinal Anesthesia in Perfusion İndex in 79 participants. Status unknown.

Timeline
1 September 2021
Primary endpoint
30 December 2021
30 December 2021

Quick facts

Lead sponsorDerince Training and Research Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment79
Start date1 September 2021
Primary completion30 December 2021
Estimated completion30 December 2021
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Derince Training and Research Hospital

Who can join

18 and older, female only, with Perfusion İndex. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Spinal anesthesia (SA) is the most preferred method of anesthesia in cesarean deliveries because it eliminates the potential risks associated with airway management in pregnant women. Spinal anesthesia poses a risk of hypotension with an incidence of approximately 70%, resulting from decreased vascular tone due to sympathetic block. Hypotension can cause dizziness in the mother, nausea and vomiting, and acidosis in the fetus. Therefore, the prevention and treatment of postspinal hypotension has been an important area of research in obstetric anesthesia. The Perfusion Index (PI) is the ratio of pulsatile blood flow (arterial chamber) to non-pulsatile static blood flow (venous and capillaries) in a patient's peripheral tissue, such as the fingertip, toe, or earlobe. This can be obtained from a pulse oximeter. This is non-invasive and continuous monitoring. The pulse variability index (PVI) represents changes in PI that occur during one or more complete respiratory cycles. PVI is found by calculating over PI changes. Allows evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes. In our work; We will simultaneously observe PI and PVI changes in the lower and upper extremities in the study group patients. When we look at the previous studies; we see that the parameters (PI and PVI) that we will look at are evaluated with different combinations in our study group patients. When we look at these studies again; We saw that contradictory results were obtained for the same parameters. In our study, patients will be verbally informed in detail about the study in the preoperative period and their consent will be obtained. While the patients are taken to the operating room and monitored, the saturation probe will be connected to the 2nd finger of the upper and lower extremities of the patients, and the PI and PVI values in both extremities will be measured simultaneously. PI and PVI values and vital values (SAB, MAP, HR, SPO2) in both extremities before spinal anesthesia; intraoperative SAP, MAP, HR, SPO2, ephedrine requirement, atropine requirement and PI and PVI values in both extremities will be recorded. As a result; In our study, we aimed to observe simultaneous changes in PI and PVI in the lower and upper extremities in pregnant patients who will undergo cesarean section under spinal anesthesia, which is our study group.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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