Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05269537

Collaborator

(none)

Enrollment

Location

3.1

Anticipated Duration (Months)

19.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Spinal Cesarean Section Echocardiography Cardiac Output	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

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 12, 2022

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

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

Arm

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.

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: 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: 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: 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.

Drug: Oxytocin

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

Outcome Measures

Primary Outcome Measures

Changes in cardiac output [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 Outcome Measures

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]
Systolic blood pressure <80% of baseline
Incidence of severe hypotension [From intrathecal injection to the end of cesarean delivery]
Systolic blood pressure <70% of baseline
Incidence of bradycardia [From intrathecal injection to the end of cesarean delivery]
Heart rate <50 beats/min
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals	Mansoura	Dakahlia	Egypt	35516

Sponsors and Collaborators

Mansoura University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT05269537

Other Study ID Numbers: