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

Perfusion Index Predicts Post-spinal Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186091
• Other study ID #: N-5- 2017
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2018
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Perfusion Index Predicts Post-spinal Hypotension

Intervention

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

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla Mohamed	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	correlation between BMI and the incidence of post-spinal hypotension	correlation between BMI and the incidence of post-spinal hypotension	24 hours Postoperative