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Not yet recruiting NCT06847737

Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods

Observational Postspinal Hypotension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: perfusion index.
Who it may be relevant to
Registry conditions: Postspinal Hypotension. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods: Comparative Analysis of Perfusion Index, Pulse Variability Index, Tissue Oxygen Saturation and Tissue Hemoglobin Index

Overview

To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.

Interventions

  • Diagnostic test perfusion index
    To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.

Primary outcome measures

  • tissue oxygen saturation [Time frame: 4 month]
  • tissue hemoglobin index [Time frame: 4 month]

Eligibility criteria

Inclusion criteria

  • Those who underwent elective cesarean section over the age of 18,
  • American Society of Anesthesia I and II,
  • Agree to participate in the study,

Exclusion criteria

  • <18 or >45 years,
  • preeclampsia,
  • cardiovascular disorders,
  • fetal abnormalities,
  • not undergoing spinal anesthesia or undergoing general anesthesia during surgery,
  • not agreeing to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

Publications

  • Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12. PMID 22798273
  • Kuwata S, Suehiro K, Juri T, Tsujimoto S, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Pleth variability index can predict spinal anaesthesia-induced hypotension in patients undergoing caesarean delivery. Acta Anaesthesiol Scand. 2018 Jan;62(1):75-84. doi: 10.1111/aas.13012. Epub 2017 Oct 16. PMID 29034983
  • Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16. PMID 28890560

Identifiers

NCT: NCT06847737 · haseki nırs masimo

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗