Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry

NCT ID: NCT06236217

Last Updated: 2024-02-01

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-07-01

Brief Summary

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This research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section.

Detailed Description

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Spinal anesthesia is the procedure of choice for elective cesarean section (CS) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus.

Accurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. More than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism.

The baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient.

Conditions

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Spinal Anesthesia Hypotension Cesarian Section Carotid Artery Corrected Flow Time Cardiometry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

Patients received standard of care with no intervention before spinal anesthesia.

Group Type NO_INTERVENTION

No interventions assigned to this group

Carotid Ultrasound group

The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.

Group Type EXPERIMENTAL

Carotid Ultrasound

Intervention Type OTHER

The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.

Electrical cardiometry group

Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.

Group Type EXPERIMENTAL

Electrical cardiometry

Intervention Type OTHER

Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.

Interventions

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Carotid Ultrasound

The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.

Intervention Type OTHER

Electrical cardiometry

Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status II.
* Gestational age (GA) ≥ 36 weeks.
* Women planned elective cesarean section under spinal anesthesia.

Exclusion Criteria

* Patient refusal to participate in the study.
* Gestational age of \< 36 or ≥40 weeks of pregnancy.
* Pregnancy-induced hypertension.
* Diabetes.
* Cardiovascular diseases, arrhythmia.
* Antepartum hemorrhage.
* Body Mass Index (BMI) above 36 kg/m2.
* Clinical fetal complications.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Mahmoud Shehab

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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34801/07/21

Identifier Type: -

Identifier Source: org_study_id

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