Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

Cesarean Section Clinical Trial

Official title:

Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia. A Prospective Observational Study Using Transthoracic Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269537
• Other study ID #: MS.20.08.1232
• Status: Completed
• Start date: March 12, 2022
• Est. completion date: July 2, 2022

Study information

• Verified date: November 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiac output will be measured in healthy parturients undergoing cesarean delivery under spinal anesthesia

Description:

ASA-II women undergoing cesarean delivery under spinal anesthesia will be included. Cardiac output will be measured using transthoracic echocardiography at 4 time points: Baseline, after 10 minutes of intrathecal injection, after delivery, and after 1 hour of intrathecal injection. Spinal anesthesia will be administered with 2.5 ml bupivacaine 0.5% and fentanyl 15 μg.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2, 2022
• Est. primary completion date: July 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status II parturients.
• Full term, singleton pregnancy
• Elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

• Height <150 cm
• Weight <60 kg
• Body mass index (BMI) <18.5 or = 35 kg/m²
• Women presenting in labor
• Contraindications to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection
• Hemoglobin <10 g/dL
• Current administration of vasoactive drugs (e.g., salbutamol, thyroxin)
• Diabetes mellitus, cardiovascular, or renal disease
• Chronic or pregnancy-induced hypertension
• Polyhydramnios
• Women with high risk for postpartum hemorrhage or uterine atony (e.g., placenta accreta spectrum, =3 previous cesarean deliveries)

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Cardiac Output
• Cesarean Section
• Echocardiography

Intervention

Radiation:
• Transthoracic Echocardiography
Measurement of cardiac output in supine position with left lateral tilt at baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection

Procedure:
• Spinal Anesthesia
Performed at the L3-L4 or L4-L5 interspace using 25-gauge spinal needle

Drug:
• Intrathecal Bupivacaine
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
• Intrathecal Fentanyl
Fentanyl 15 µg will be administered in the subarachnoid space
• Crystalloid Coload 1000 mL
Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection

Procedure:
• Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

Drug:
• Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
• Oxytocin
Intravenous oxytocin 10 U in 500 mL Ringer acetate will be administered over 30 minutes starting immediately after delivery of the fetus

Locations

Country	Name	City	State
Egypt	Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cardiac output	Cardiac output measured using transthoracic echocardiography	At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Secondary	Changes in stroke volume		At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Secondary	Changes in heart rate		At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Secondary	Number of subjects requiring ephedrine		From intrathecal injection to the end of cesarean delivery
Secondary	Incidence of hypotension	Systolic blood pressure <80% of baseline	From intrathecal injection to the end of cesarean delivery
Secondary	Incidence of severe hypotension	Systolic blood pressure <70% of baseline	From intrathecal injection to the end of cesarean delivery
Secondary	Incidence of bradycardia	Heart rate <50 beats/min	From intrathecal injection to the end of cesarean delivery
Secondary	Incidence of nausea and/or vomiting		From intrathecal injection to the end of cesarean delivery
Secondary	Neonatal Apgar scores		At 1 and 5 minutes after delivery