Perfusion Index and Pleth Variability Index in Cesarean Section.

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195087
• Other study ID #: AntalyaEAH02
• Status: Completed
• Start date: December 2, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2020
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 28, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Device:
• Masimo Radical-7® Pulse CO-Oximeter®
The perfusion index and Pleth variability index will be recorded from the device monitor.

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Antalya Training and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion index	Perfusion index will be recorded from the monitor.	Before spinal anesthesia in supine positon
Primary	Pleth variability index	Pleth variability index will be recorded from the monitor.	Before spinal anesthesia in supine positon
Primary	Perfusion index	Perfusion index will be recorded from the monitor.	Before spinal anesthesia in sitting positon
Primary	Pleth variability index	Pleth variability index will be recorded from the monitor.	Before spinal anesthesia in sitting positon
Primary	Perfusion index	Perfusion index will be recorded from the monitor.	1 minutes after spinal anesthesia in supine positon
Primary	Pleth variability index	Pleth variability index will be recorded from the monitor.	1 minutes after spinal anesthesia in supine positon
Primary	Perfusion index	Perfusion index will be recorded from the monitor.	Start of the surgery
Primary	Pleth variability index	Pleth variability index will be recorded from the monitor.	Start of the surgery
Primary	Perfusion index	Perfusion index will be recorded from the monitor.	1 minutes after the umbilical cord clamping
Primary	Pleth variability index	Pleth variability index will be recorded from the monitor.	1 minutes after the umbilical cord clamping