Clinical trial NCT04195087: Perfusion Index and Pleth Variability Index in Cesarean Section.
Official title: Perfusion Index and Pleth Variability Index in Predicting Hypotension Following Spinal Anesthesia Performed in Sitting Position in Cesarean Section.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Keywords: cesarean section
perfusion index
Pleth variability index
sitting position
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-11
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who will undergo elective cesarean section

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perfusion index
timeFrame: Before spinal anesthesia in supine positon
measure: Pleth variability index
timeFrame: Before spinal anesthesia in supine positon
measure: Perfusion index
timeFrame: Before spinal anesthesia in sitting positon
measure: Pleth variability index
timeFrame: Before spinal anesthesia in sitting positon
measure: Perfusion index
timeFrame: 1 minutes after spinal anesthesia in supine positon
measure: Pleth variability index
timeFrame: 1 minutes after spinal anesthesia in supine positon
measure: Perfusion index
timeFrame: Start of the surgery
measure: Pleth variability index
timeFrame: Start of the surgery
measure: Perfusion index
timeFrame: 1 minutes after the umbilical cord clamping
measure: Pleth variability index
timeFrame: 1 minutes after the umbilical cord clamping
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: University of Health Sciences, Antalya Training and Research Hospital
Study officials:
affiliation: University of Health Sciences, Antalya Training and Research Hospital
name: Erhan OZYURT, MD
role: STUDY_DIRECTOR
References: