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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06236217
Enrollment
300
Registered
2024-02-01
Start date
2021-08-01
Completion date
2023-07-01
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia, Hypotension, Cesarian Section, Carotid Artery, Corrected Flow Time, Cardiometry

Brief summary

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

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.

Interventions

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

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of post-spinal hypotensionIntraoperativelyIncidence of spinal anesthesia-induced hypotension was measured. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg).

Secondary

MeasureTime frameDescription
The amount of intravenous fluidsIntraoperativelyThe amount of intravenous fluids was assessed.
The amount of vasopressorIntraoperativelyThe amount of vasopressor was assessed. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg).
Umbilical cord PHImmediately after fetal deliveryUmbilical cord PH was measured with fetal delivery.
Neonatal APGAR score5 minutes after fetal deliveryNeonatal APGAR score is a score between 7-10 is normal; a score between 4-6 needs proper reevaluation as the infant does require monitoring for 5 minutes. It was measured at 1, 5 minutes.
ComplicationsIntraoperativelyComplications such as bradycardia, pruritis and urine retention were measured

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026