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Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05269537
Enrollment
60
Registered
2022-03-08
Start date
2022-03-12
Completion date
2022-07-02
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal, Cesarean Section, Echocardiography, Cardiac Output

Brief summary

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

Detailed 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.

Interventions

RADIATIONTransthoracic 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

PROCEDURESpinal Anesthesia

Performed at the L3-L4 or L4-L5 interspace using 25-gauge spinal needle

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Fentanyl 15 μg will be administered in the subarachnoid space

Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection

PROCEDURECesarean Delivery

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.

DRUGOxytocin

Intravenous oxytocin 10 U in 500 mL Ringer acetate will be administered over 30 minutes starting immediately after delivery of the fetus

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Changes in cardiac outputAt baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injectionCardiac output measured using transthoracic echocardiography

Secondary

MeasureTime frameDescription
Changes in heart rateAt baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Number of subjects requiring ephedrineFrom intrathecal injection to the end of cesarean delivery
Incidence of hypotensionFrom intrathecal injection to the end of cesarean deliverySystolic blood pressure \<80% of baseline
Changes in stroke volumeAt baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Incidence of bradycardiaFrom intrathecal injection to the end of cesarean deliveryHeart rate \<50 beats/min
Incidence of nausea and/or vomitingFrom intrathecal injection to the end of cesarean delivery
Neonatal Apgar scoresAt 1 and 5 minutes after delivery
Incidence of severe hypotensionFrom intrathecal injection to the end of cesarean deliverySystolic blood pressure \<70% of baseline

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026