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

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

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.

Study Overview

• Status: Completed
• Conditions: Perfusion Index Predicts Post-spinal Hypotension
• Intervention / Treatment: Procedure: correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between baseline perfusion index and post spinal decrease in systolic blood pressure	correlation between baseline perfusion index and post spinal decrease in systolic blood pressure	24 hours Postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between BMI and the incidence of post-spinal hypotension	correlation between BMI and the incidence of post-spinal hypotension	24 hours Postoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ahmed Abdalla Mohamed, M.D, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): July 9, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: N-5- 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Till submission

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No