Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia
Completed
- Conditions
- Cardiac OutputCesarean SectionAnesthesia, SpinalEchocardiography
- Interventions
- Radiation: Transthoracic EchocardiographyProcedure: Spinal AnesthesiaDrug: Crystalloid Coload 1000 mLProcedure: Cesarean Delivery
- Registration Number
- NCT05269537
- Lead Sponsor
- Mansoura University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Group Intravenous Ephedrine 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. Study Group Intrathecal Bupivacaine 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. Study Group Intrathecal Fentanyl 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. Study Group Transthoracic Echocardiography 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. Study Group Spinal Anesthesia 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. Study Group Crystalloid Coload 1000 mL 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. Study Group Cesarean Delivery 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. Study Group Oxytocin 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Systolic blood pressure \<70% of baseline
Incidence of bradycardia From intrathecal injection to the end of cesarean delivery Heart rate \<50 beats/min
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 Systolic blood pressure \<80% of baseline
Incidence of nausea and/or vomiting From intrathecal injection to the end of cesarean delivery
Trial Locations
- Locations (1)
Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals
🇪🇬Mansoura, Dakahlia, Egypt