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Completed

NCT Number: NCT05269537

Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

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

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Key information

Conditions

Anesthesia, Spinal Cardiac Output Cesarean Section Echocardiography

Age range

19 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transthoracic Echocardiography

Radiation

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

Spinal anesthesia

Procedure

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

Intrathecal Bupivacaine

Drug

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

Intrathecal Fentanyl

Drug

Fentanyl 15 μg will be administered in the subarachnoid space

Crystalloid Coload 1000 mL

Drug

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

Cesarean Delivery

Procedure

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

Intravenous Ephedrine

Drug

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

Oxytocin

Drug

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

Primary outcomes

  1. Changes in cardiac output

    Time frame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection

    Cardiac output measured using transthoracic echocardiography

Secondary outcomes

  1. Changes in stroke volume

    Time frame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection

  2. Changes in heart rate

    Time frame: At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection

  3. Number of subjects requiring ephedrine

    Time frame: From intrathecal injection to the end of cesarean delivery

  4. Incidence of hypotension

    Time frame: From intrathecal injection to the end of cesarean delivery

    Systolic blood pressure <80% of baseline

  5. Incidence of severe hypotension

    Time frame: From intrathecal injection to the end of cesarean delivery

    Systolic blood pressure <70% of baseline

  6. Incidence of bradycardia

    Time frame: From intrathecal injection to the end of cesarean delivery

    Heart rate <50 beats/min

  7. Incidence of nausea and/or vomiting

    Time frame: From intrathecal injection to the end of cesarean delivery

  8. Neonatal Apgar scores

    Time frame: At 1 and 5 minutes after delivery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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