Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia. A Prospective Observational Study Using Transthoracic Echocardiography
Overview
- Phase
- Not Applicable
- Intervention
- Transthoracic Echocardiography
- Conditions
- Anesthesia, Spinal
- Sponsor
- Mansoura University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in cardiac output
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Mohamed Mohamed Tawfik
Assistant Professor, Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals, Mansoura, Egypt
Mansoura University
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
Arms & Interventions
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.
Intervention: Transthoracic Echocardiography
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.
Intervention: Spinal Anesthesia
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.
Intervention: Intrathecal Bupivacaine
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.
Intervention: Intrathecal Fentanyl
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.
Intervention: Crystalloid Coload 1000 mL
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.
Intervention: Cesarean Delivery
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.
Intervention: Intravenous Ephedrine
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.
Intervention: Oxytocin
Outcomes
Primary Outcomes
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
- Number of subjects requiring ephedrine(From intrathecal injection to the end of cesarean delivery)
- Incidence of severe hypotension(From intrathecal injection to the end of cesarean delivery)
- Incidence of bradycardia(From intrathecal injection to the end of cesarean delivery)
- Neonatal Apgar scores(At 1 and 5 minutes after delivery)
- Changes in heart rate(At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection)
- Changes in stroke volume(At baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection)
- Incidence of hypotension(From intrathecal injection to the end of cesarean delivery)
- Incidence of nausea and/or vomiting(From intrathecal injection to the end of cesarean delivery)