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

T

Tanta University

Status

Completed

Conditions

Carotid Artery
Hypotension
Spinal Anesthesia
Cesarian Section
Corrected Flow Time
Cardiometry

Treatments

Other: Carotid Ultrasound
Other: Electrical cardiometry

Study type

Interventional

Funder types

Other

Identifiers

NCT06236217
34801/07/21

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 3 patient groups

Control group
No Intervention group
Description:
Patients received standard of care with no intervention before spinal anesthesia.
Carotid Ultrasound group
Experimental group
Description:
The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.
Treatment:
Other: Carotid Ultrasound
Electrical cardiometry group
Experimental group
Description:
Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.
Treatment:
Other: Electrical cardiometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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