Perfusion Index vs Positional Hemodynamic Changes to Predict Hypotension After Spinal Anaesthesia in Caesarean Section

Comparative Study Between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension After Spinal Anaesthesia in Caesarean Section

Comparative Study between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension after Spinal Anaesthesia in Caesarean Section

Study Overview

• Status: Recruiting
• Conditions: Post Spinal Hypotension
• Intervention / Treatment: Other: perfusion index in all parturient recruited for the study

Detailed Description

Hypotension following spinal anaesthesia may cause maternal dizziness, nausea, vomiting and fetal acidosis, administration of prophylactic vasopressor agents in pregnant women may cause undesirable effects on the mother and fetus. Perfusion index is the ratio of a pulsatile to a non-pulsatile fraction of blood volume. The increase of the pulsatile fraction manifested during vasodilatation corresponds to a higher PI. So, the patients with a higher PI have a higher risk for post-spinal hypotension. Elevated sympathetic activity before neuraxial anaesthesia was associated with a higher risk for post-spinal hypotension. The significant variability in haemodynamic after the positional change indicates higher sympathetic activity. The high the rise in autonomic activity, the higher the risk for post-spinal hypotension

AIM OF THE WORK:

Prediction of hypotension after spinal anaesthesia in caesarean section either by perfusion index and positional haemodynamic changes

Grouping:

All the recruited patients will be assessed by perfusion index. and by positional haemodynamic changes

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Ramy M Husin, M.B.B. Ch; Phone Number: 002 01128601089; Email: ramy23m@gmail.com
• Study Contact Backup: Name: Naglaa F Abdelhaleem; Phone Number: 01003103036; Email: nogaahmedkareem.fa@gmail.com

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Recruiting
    • Faculty of medicine
    • Contact: Ramy M Husin, M.B.B. Ch; Phone Number: 01128601089; Email: ramy23m@gmail.com
    • Contact: Naglaa abdelhaleem, MD; Phone Number: 01003103036; Email: nogaahmedkareem.fa@gmail.com
  • Zagazig, Egypt
    • Recruiting
    • Ramy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women undergoing an elective caesarean section delivery.

Description

Inclusion criteria

• Parturient acceptance.
• American Society of Anesthesiologists (ASA) II
• arturient with be gestational age >36 weeks and <41 weeks.
• Body mass index (BMI) ≤35kg/m2
• elective caesarean section delivery

Exclusion criteria

• preeclampsia
• eclampsia,
• gestational diabetes
• Contraindication to regional anaesthesia as allergy, coagulation abnormalities or infection in site of injection.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational study in parturient who will be recruited for the study; this study will include the eligible parturient who will be assessed by perfusion index and by positional hemodynamic changes.	Other: perfusion index in all parturient recruited for the study; Using perfusion index and positional hemodynamic changes for the prediction of postspinal hypotension in all parturient recruited for the study; Other Names: positional haemodynamic changes between supine and right lateral position in parturient .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of post-spinal hypotension using PI	To correlate between perfusion index and hypotension after spinal anaesthesia in caesarean section	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of post-spinal hypotension using positional hemodynamic changes	To correlate between positional haemodynamic changes and hypotension after spinal anaesthesia in caesarean section	6 months

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: Naglaa Abdelhaleem, MD, Faculty of medicine, Zagazig University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 9293/2-2-2022

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No