Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

NCT ID: NCT05269537

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-12
• Study Completion Date: 2022-07-02

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.

Conditions

Anesthesia, Spinal; Cesarean Section; Echocardiography; Cardiac Output

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Transthoracic Echocardiography

Intervention Type: 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

Intervention Type: PROCEDURE

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

Intrathecal Bupivacaine

Intervention Type: DRUG

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

Intrathecal Fentanyl

Intervention Type: DRUG

Fentanyl 15 μg will be administered in the subarachnoid space

Crystalloid Coload 1000 mL

Intervention Type: DRUG

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

Cesarean Delivery

Intervention Type: PROCEDURE

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

Intravenous Ephedrine

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: RADIATION

Spinal Anesthesia

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

Intervention Type: PROCEDURE

Intrathecal Bupivacaine

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

Intervention Type: DRUG

Intrathecal Fentanyl

Fentanyl 15 μg will be administered in the subarachnoid space

Intervention Type: DRUG

Crystalloid Coload 1000 mL

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

Intervention Type: DRUG

Cesarean Delivery

Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Oxytocin

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mohamed Tawfik

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed M Tawfik, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MS.20.08.1232

Identifier Type: -

Identifier Source: org_study_id