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Completed

NCT Number: NCT04195087

Perfusion Index and Pleth Variability Index in Cesarean Section.

The aim of this study is to investigate the predictability of hypotension by using PI and PVI in pre-and post-spinal anesthesia periods in cesarean section cases in the sitting position.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Health Sciences, Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

About this study

Spinal anesthesia has been widely used all over the world due to its superiority to general anesthesia in cesarean section. However, as a result of the sympathetic blockade in spinal anesthesia, vascular tone decreases and hypotension occurs. The incidence of hypotension increases up to 70% in pregnant women due to increased sensitivity to local anesthetics and increased intraabdominal pressure. Improper management of postspinal hypotension may lead to maternal and fetal complications. Predicting the risk of hypotension in patients undergoing spinal anesthesia may allow applications such as volume loading or prophylactic vasopressor use. The perfusion index, measured by pulse Oximeters, correlates with blood flow changes at the tip of the finger so that it can detect hypotension and thus decrease in blood flow after spinal anesthesia. Pleth variability index (PVI) is a non-invasive value found in the new generation pulse oximeters. It is a parameter used in the dynamic measurement of response to fluid therapy in intensive care units. PVI can dynamically give an idea about the fluid status of the pregnant woman. Previous studies have shown that PVI may be a marker for predicting hypotension following spinal anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women who will undergo elective cesarean section

Exclusion criteria

  • Preeclampsia
  • Cardiovascular disorder
  • Fetal abnormality
  • Patients who failed spinal anesthesia or switched to general anesthesia during operation.

Treatment and study plan

Masimo Radical-7® Pulse CO-Oximeter®

Device

The perfusion index and Pleth variability index will be recorded from the device monitor.

Primary outcomes

  1. Perfusion index

    Time frame: Before spinal anesthesia in supine positon

    Perfusion index will be recorded from the monitor.

  2. Pleth variability index

    Time frame: Before spinal anesthesia in supine positon

    Pleth variability index will be recorded from the monitor.

  3. Perfusion index

    Time frame: Before spinal anesthesia in sitting positon

    Perfusion index will be recorded from the monitor.

  4. Pleth variability index

    Time frame: Before spinal anesthesia in sitting positon

    Pleth variability index will be recorded from the monitor.

  5. Perfusion index

    Time frame: 1 minutes after spinal anesthesia in supine positon

    Perfusion index will be recorded from the monitor.

  6. Pleth variability index

    Time frame: 1 minutes after spinal anesthesia in supine positon

    Pleth variability index will be recorded from the monitor.

  7. Perfusion index

    Time frame: Start of the surgery

    Perfusion index will be recorded from the monitor.

  8. Pleth variability index

    Time frame: Start of the surgery

    Pleth variability index will be recorded from the monitor.

  9. Perfusion index

    Time frame: 1 minutes after the umbilical cord clamping

    Perfusion index will be recorded from the monitor.

  10. Pleth variability index

    Time frame: 1 minutes after the umbilical cord clamping

    Pleth variability index will be recorded from the monitor.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Perfusion Index and Pleth Variability Index in Predicting Hypotension Following Spinal Anesthesia Performed in Sitting Position in Cesarean Section.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2019
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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