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

NCT06236217 | Completed

• 1 other identifier: 34801/07/21
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The amount of intravenous fluids

  Intraoperatively

• The amount of vasopressor

  Intraoperatively

• Umbilical cord PH

  Immediately after fetal delivery

• Neonatal APGAR score

  5 minutes after fetal delivery

• Complications

  Intraoperatively

Study Arms (3)

Control group

NO INTERVENTION

Patients received standard of care with no intervention before spinal anesthesia.

Carotid Ultrasound group

EXPERIMENTAL

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

Other: Carotid Ultrasound

Electrical cardiometry group

EXPERIMENTAL

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

Other: Electrical cardiometry

Interventions

Carotid Ultrasound OTHER

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

Carotid Ultrasound group

Electrical cardiometry OTHER

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

Electrical cardiometry group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women elective cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years.
• American Society of Anesthesiologists (ASA) physical status II.
• Gestational age (GA) ≥ 36 weeks.
• Women planned elective cesarean section under spinal anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: August 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)