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Clinical Trials/NCT03864692
NCT03864692
Completed
Not Applicable

Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for Caesarean Section

Kahramanmaras Sutcu Imam University1 site in 1 country88 target enrollmentJanuary 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section Complications
Sponsor
Kahramanmaras Sutcu Imam University
Enrollment
88
Locations
1
Primary Endpoint
Perfusion index (PI)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration.

Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone.

Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness.

The aim of this study is to investigate whether the PI and PVI values at different patient positions can predict hypotension during caesarean section.

Registry
clinicaltrials.gov
Start Date
January 22, 2019
End Date
March 14, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Responsible Party
Principal Investigator
Principal Investigator

MAHMUT ARSLAN

Assistant Professor

Kahramanmaras Sutcu Imam University

Eligibility Criteria

Inclusion Criteria

  • singleton parturient
  • planned for elective LSCS under spinal anesthesia

Exclusion Criteria

  • gestational age \< 36 weeks
  • emergency cases
  • placenta previa, pre-eclampsia
  • Reynauld disease
  • patient refusal
  • cardiovascular disease

Outcomes

Primary Outcomes

Perfusion index (PI)

Time Frame: perioperative

PI values (%) at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

pleth variability index (PVI)

Time Frame: perioperative

PVI values (%)at supine, head-up, head-down, lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

Secondary Outcomes

  • heart rate(perioperative)

Study Sites (1)

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