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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06236217
• Other study ID #: 34801/07/21
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometry
• Hypotension
• Spinal Anesthesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The amount of intravenous fluids	The amount of intravenous fluids was assessed.	Intraoperatively
Secondary	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
Secondary	Umbilical cord PH	Umbilical cord PH was measured with fetal delivery.	Immediately after fetal delivery
Secondary	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
Secondary	Complications	Complications such as bradycardia, pruritis and urine retention were measured	Intraoperatively