Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

NCT05269537 | Completed

• 1 other identifier: MS.20.08.1232
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, Spinal; Cesarean Section; Echocardiography; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  From intrathecal injection to the end of cesarean delivery

• Incidence of severe hypotension

  From intrathecal injection to the end of cesarean delivery

Study Arms (1)

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.

Radiation: Transthoracic Echocardiography; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Drug: Crystalloid Coload 1000 mL; Procedure: Cesarean Delivery; Drug: Intravenous Ephedrine; Drug: Oxytocin

Interventions

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

Study Group

Spinal Anesthesia PROCEDURE

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

Study Group

Intrathecal Bupivacaine DRUG

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

Study Group

Intrathecal Fentanyl DRUG

Fentanyl 15 μg will be administered in the subarachnoid space

Study Group

Crystalloid Coload 1000 mL DRUG

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

Study Group

Cesarean Delivery PROCEDURE

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

Study Group

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.

Study Group

Oxytocin DRUG

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

Study Group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Spinal; Cesarean Section; Oxytocin

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed M Tawfik, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals, Mansoura, Egypt

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 8, 2022
• Study Start: March 12, 2022
• Primary Completion: July 2, 2022
• Study Completion: July 2, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)