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

Not Applicable

Completed

• Conditions: Cardiometry; Spinal Anesthesia; Corrected Flow Time; Hypotension; Cesarian Section; Carotid Artery
• Interventions: Other: Carotid Ultrasound; Other: Electrical cardiometry

• Registration Number: NCT06236217
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid Ultrasound group	Carotid Ultrasound	The carotid artery corrected flow time (FTc) was used in patients to optimize the volume status before performing spinal anesthesia.
Electrical cardiometry group	Electrical cardiometry	Stroke volume variation (SVV) measured by electrical cardiometry (EC) was used to optimize the volume status before performing spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
The incidence of post-spinal hypotension	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 Outcome Measures

Name	Time	Method
Complications	Intraoperatively	Complications such as bradycardia, pruritis and urine retention were measured
The amount of vasopressor	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).
The amount of intravenous fluids	Intraoperatively	The amount of intravenous fluids was assessed.
Umbilical cord PH	Immediately after fetal delivery	Umbilical cord PH was measured with fetal delivery.
Neonatal APGAR score	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt