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

NCT06847737 | Not Yet Recruiting

• 1 other identifier: haseki nırs masimo
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postspinal Hypotension

Outcome Measures

Primary Outcomes (2)

• tissue oxygen saturation

  which indicates an increase in local tissue perfusion

  4 month

• tissue hemoglobin index

  indicating vasodilation

  4 month

Interventions

perfusion index DIAGNOSTIC_TEST

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.

Also known as: pleth variability index, tissue hemoglobin index, tissue oxygen saturation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women who will have a cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Fifty pregnant women over the age of 18 who underwent elective cesarean section, were American Society of Anesthesia I and II, and agreed to participate in the study.

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: July 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)