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NCT Number: NCT06236217

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

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.

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Key information

Conditions

Spinal Anesthesia Cardiometry Cardiovascular Diseases Carotid Artery Cesarian Section Corrected Flow Time Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid Ultrasound

Other

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

Electrical cardiometry

Other

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

Primary outcomes

  1. The incidence of post-spinal hypotension

    Time frame: Intraoperatively

    Incidence 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 outcomes

  1. The amount of intravenous fluids

    Time frame: Intraoperatively

    The amount of intravenous fluids was assessed.

  2. The amount of vasopressor

    Time frame: Intraoperatively

    The 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).

  3. Umbilical cord PH

    Time frame: Immediately after fetal delivery

    Umbilical cord PH was measured with fetal delivery.

  4. Neonatal APGAR score

    Time frame: 5 minutes after fetal delivery

    Neonatal 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.

  5. Complications

    Time frame: Intraoperatively

    Complications such as bradycardia, pruritis and urine retention were measured

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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