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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Cardiac Output; Anesthesia, Spinal; Echocardiography
• Intervention / Treatment: Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Drug: Intravenous Ephedrine; Radiation: Transthoracic Echocardiography; Procedure: Spinal Anesthesia; Drug: Crystalloid Coload 1000 mL; Procedure: Cesarean Delivery; Drug: Oxytocin

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Healthy women with full term, singleton pregnancy presenting for elective cesarean delivery under spinal anesthesia in a tertiary obstetric hospital

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Group; Cardiac output will be measured at baseline using transthoracic echocardiography. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl. Crystalloid coload 1000 mL will be administered: Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection. Cardiac output will be measured at 10 minutes after intrathecal injection, immediately after delivery, at 1 hour after intrathecal injection. Cesarean delivery will be performed. Intravenous ephedrine will be administered to correct hypotension. After delivery, 10 units of oxytocin in 500 ml Ringer acetate will be administered over 30 minutes.

Drug: Intrathecal Bupivacaine; Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space; Drug: Intrathecal Fentanyl; Fentanyl 15 μg will be administered in the subarachnoid space; 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.; 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: 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: Oxytocin; Intravenous oxytocin 10 U in 500 mL Ringer acetate will be administered over 30 minutes starting immediately after delivery of the fetus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in stroke volume		At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Changes in heart rate		At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection
Number of subjects requiring ephedrine		From intrathecal injection to the end of cesarean delivery
Incidence of hypotension	Systolic blood pressure <80% of baseline	From intrathecal injection to the end of cesarean delivery
Incidence of severe hypotension	Systolic blood pressure <70% of baseline	From intrathecal injection to the end of cesarean delivery
Incidence of bradycardia	Heart rate <50 beats/min	From intrathecal injection to the end of cesarean delivery
Incidence of nausea and/or vomiting		From intrathecal injection to the end of cesarean delivery
Neonatal Apgar scores		At 1 and 5 minutes after delivery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Mohamed M Tawfik, MD, Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals, Mansoura, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2022
• Primary Completion (Actual): July 2, 2022
• Study Completion (Actual): July 2, 2022

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Reproductive Control Agents; Central Nervous System Stimulants; Oxytocics; Sympathomimetics; Vasoconstrictor Agents; Fentanyl; Oxytocin; Bupivacaine; Ephedrine
• Other Study ID Numbers: MS.20.08.1232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No