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

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05587153
Collaborator
(none)
80
Enrollment
2
Locations
5.5
Anticipated Duration (Months)
40
Patients Per Site
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparative Study Between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension After Spinal Anaesthesia in Caesarean Section
Actual Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm 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 .

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prediction of post-spinal hypotension using PI [6 months]

      To correlate between perfusion index and hypotension after spinal anaesthesia in caesarean section

    Secondary Outcome Measures

    1. Prediction of post-spinal hypotension using positional hemodynamic changes [6 months]

      To correlate between positional haemodynamic changes and hypotension after spinal anaesthesia in caesarean section

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine Zagazig Egypt 44519
    2 Ramy Zagazig Egypt

    Sponsors and Collaborators

    • Zagazig University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05587153
    Other Study ID Numbers:
    • 9293/2-2-2022
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Dec 23, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypotension

    Study Results

    No Results Posted as of Dec 23, 2022