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Clinical Trials/NCT06236217
NCT06236217
Completed
N/A

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

Tanta University1 site in 1 country300 target enrollmentAugust 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Anesthesia
Sponsor
Tanta University
Enrollment
300
Locations
1
Primary Endpoint
The incidence of post-spinal hypotension
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
July 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mostafa Mahmoud Shehab

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

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/m
  • Clinical fetal complications.

Outcomes

Primary Outcomes

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

  • Complications(Intraoperatively)
  • The amount of vasopressor(Intraoperatively)
  • The amount of intravenous fluids(Intraoperatively)
  • Umbilical cord PH(Immediately after fetal delivery)
  • Neonatal APGAR score(5 minutes after fetal delivery)

Study Sites (1)

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