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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Spinal Anesthesia; Cardiometry; Cesarian Section; Carotid Artery; Corrected Flow Time
• Intervention / Treatment: Other: Carotid Ultrasound; Other: Electrical cardiometry

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of post-spinal hypotension	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).	Intraoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 34801/07/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No