Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
Not Applicable
Completed
- Conditions
- Anesthesia, SpinalCesarean Section
- Interventions
- Drug: 500 mL Colloid PreloadProcedure: Spinal AnesthesiaDrug: 1000 mL Crystalloid ColoadDrug: 500 mL Crystalloid ColoadProcedure: Cesarean DeliveryRadiation: Ultrasound Assessment of the Inferior Vena Cava
- Registration Number
- NCT02961842
- Lead Sponsor
- Mansoura University
- Brief Summary
The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.
- Detailed Description
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
Inclusion Criteria
- American Society of Anesthesiologists physical status II parturients
- Full term, singleton pregnancy
- Elective cesarean delivery under spinal anesthesia
Exclusion Criteria
- Age <19 or > 40 years
- Height <150 cm
- Weight <60 kg
- Body mass index ≥40 kg/m2
- Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
- Chronic or pregnancy-induced hypertension
- Hemoglobin <10 gm/dL.
- Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
- Polyhydramnios or known fetal abnormalities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Intrathecal Fentanyl 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Coload Intrathecal Bupivacaine 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Coload Intravenous Ephedrine 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Combination Intrathecal Bupivacaine 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Combination Intravenous Ephedrine 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Combination Spinal Anesthesia 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Combination Ultrasound Assessment of the Inferior Vena Cava 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Combination 500 mL Colloid Preload 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Combination 500 mL Crystalloid Coload 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Coload Cesarean Delivery 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Combination Cesarean Delivery 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Coload Spinal Anesthesia 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Coload Intrathecal Fentanyl 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Coload 1000 mL Crystalloid Coload 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Coload Ultrasound Assessment of the Inferior Vena Cava 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered.
- Primary Outcome Measures
Name Time Method Total ephedrine dose intraoperative
- Secondary Outcome Measures
Name Time Method Incidence of severe hypotension intraoperative Severe hypotension: Systolic blood pressure \<70% of baseline
Time to the first ephedrine dose intraoperative Heart rate intraoperative Inferior vena cava largest and smallest diameters Baseline, at 1 and 5 minutes after intrathecal injection, delivery Inferior vena cava collapsibility index Baseline, at 1 and 5 minutes after intrathecal injection, delivery Collapsibility index = (Largest diameter - Smallest diameter) / Largest diameter
Incidence of nausea and/or vomiting intraoperative Neonatal Apgar score At 1 and 5 minutes after delivery Incidence of hypotension intraoperative Hypotension: Systolic blood pressure \<80% of baseline
Trial Locations
- Locations (1)
Department of Anesthesia, Mansoura University Hospitals
🇪🇬Mansoura, Dakahlia, Egypt