Perfusion Index and Pleth Variability Index in Cesarean Section.

Completed

• Conditions: Cesarean Section Complications
• Interventions: Device: Masimo Radical-7® Pulse CO-Oximeter®

• Registration Number: NCT04195087
• Lead Sponsor: Antalya Training and Research Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypotension	Masimo Radical-7® Pulse CO-Oximeter®	Patients with a 20% reduction in mean arterial pressure and/or systolic arterial pressure below 80 mmHg after spinal anesthesia.
Non-hypotension	Masimo Radical-7® Pulse CO-Oximeter®	Patients with a mean arterial pressure reduction of less than 20% and/or systolic arterial pressure above 80 mmHg after spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Pleth variability index	1 minutes after the umbilical cord clamping	Pleth variability index will be recorded from the monitor.
Perfusion index	1 minutes after the umbilical cord clamping	Perfusion index will be recorded from the monitor.

Trial Locations

Locations (1)

University of Health Sciences, Antalya Training and Research Hospital; 🇹🇷 Antalya, Turkey