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OpenTrials
Completed

NCT Number: NCT03956186

Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?

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. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

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 and 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 and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

Secondary outcomes

  1. blood pressure (mmHg)

    Time frame: perioperative

    blood pressure will be recorded

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 20, 2019
Registry last updated
Jul 24, 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.

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