Skip to main content
OpenTrials
Completed

NCT Number: NCT03864692

Prediction of Hypotension Using Perfusion Index and Pleth Variability Index After Spinal Anesthesia for C/S

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kahramanmaras Sutcu Imam University

Kahramanmaraş, In the USA Or Canada, Please Select..., 46100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • singleton parturient
  • planned for elective LSCS under spinal anesthesia

Exclusion criteria

  • gestational age < 36 weeks
  • emergency cases
  • placenta previa, pre-eclampsia
  • BMI>40
  • Reynauld disease
  • patient refusal
  • cardiovascular disease

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. heart rate

    Time frame: perioperative

    Heart rate (beat per minute) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.

Other outcomes

  1. Blood pressure

    Time frame: perioperative

    Blood pressure (mmHg) at supine, head-up, head-down and lateral positions will be recorded and compared between the 2 groups.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Jun 18, 2019

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.

Published trials that share one or more normalized conditions with this study.