MedDataX Logo

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

NCT ID: NCT05587153

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Spinal Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

perfusion index in all parturient recruited for the study

Intervention Type OTHER

Using perfusion index and positional hemodynamic changes for the prediction of postspinal hypotension in all parturient recruited for the study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

positional haemodynamic changes between supine and right lateral position in parturient .

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naglaa Abdelhaleem, MD

Role: STUDY_DIRECTOR

Faculty of medicine, Zagazig University Hospitals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of medicine

Zagazig, , Egypt

Site Status RECRUITING

Ramy

Zagazig, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ramy M Husin, M.B.B. Ch

Role: CONTACT

Phone: 01128601089

Email: [email protected]

Naglaa F Abdelhaleem

Role: CONTACT

Phone: 01003103036

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ramy M Husin, M.B.B. Ch

Role: primary

Naglaa Abdelhaleem, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9293/2-2-2022

Identifier Type: -

Identifier Source: org_study_id