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Completed

NCT Number: NCT04186091

Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section

Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

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Key information

Conditions

Perfusion Index Predicts Post-spinal Hypotension

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

Abstract Background Hypotension is a common adverse effect of spinal anesthesia during caesarean section especially in obese patients.

The aim of this study is to find out the correlation between baseline PI and post spinal hypotension in obese parturient.

Methods After approval of ethical committee and written informed consent, fifty Parturients aged between 18- 40 years, ASA I and II with term singleton pregnancies with BMI between 25 &40 admitted for cesarean section under spinal anesthesia were recruited in this prospective, observational study. The primary outcome is the correlation between baseline perfusion index and post spinal hypotension. The secondary outcome is the correlation between BMI and the incidence of hypotension after spinal anesthesia. Heart rate, blood pressure, perfusion index before and after spinal induction using Masimo device, level of sensory block, dose of ephedrine required to correct hypotension, dose of atropine required to correct bradycardia, incidence of nausea, vomiting and shivering were recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fifty parturient
  • Aged between 18- 40,
  • ASA I and II
  • With term singleton pregnancies
  • With 25 ≥ BMI≤ 40
  • Conducted for cesarean section under spinal anesthesia

Exclusion criteria

  • Emergency cases,
  • Placenta previa,
  • Preeclampsia,
  • Cardiovascular and cerebrovascular diseases,
  • Patient with contraindication for regional anesthesia
  • Patient with peripheral vascular diseases as DVT.

Treatment and study plan

correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction

Procedure

correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction

Primary outcomes

  1. correlation between baseline perfusion index and post spinal decrease in systolic blood pressure

    Time frame: 24 hours Postoperative

    correlation between baseline perfusion index and post spinal decrease in systolic blood pressure

Secondary outcomes

  1. correlation between BMI and the incidence of post-spinal hypotension

    Time frame: 24 hours Postoperative

    correlation between BMI and the incidence of post-spinal hypotension

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Perfusion Index Predicts Post-spinal Hypotension in Obese Parturients for Cesarean Section-A Prospective Observational Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2019
Registry last updated
Dec 4, 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.