Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypotension
- Sponsor
- Aretaieion University Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- incidence of hypotension
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section
Detailed Description
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading. The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.
Investigators
Dr Kassiani Theodoraki
Professor of Anesthesiology
Aretaieion University Hospital
Eligibility Criteria
Inclusion Criteria
- •adult parturients, American Society of Anesthesiologists (ASA) I-II,
- •singleton gestation\>37 weeks
- •elective cesarean section
Exclusion Criteria
- •Body Mass Index (BMI) \>40 kg/m2
- •Body weight \<50 kg
- •Body weight\>100 kg
- •height\<150 cm
- •height\>180 cm
- •multiple gestation
- •fetal abnormality
- •fetal distress
- •active labor
- •cardiac disease
Outcomes
Primary Outcomes
incidence of hypotension
Time Frame: intraoperative
any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded
Secondary Outcomes
- need for vasoconstrictor(intraoperative)
- type of vasoconstrictor administered(intraoperative)
- total dose of vasoconstrictor administered(intraoperative)
- incidence of bradycardia(intraoperative)
- need for atropine(intraoperative)
- modification or cessation of the infusion(intraoperative)
- incidence of nausea/vomiting(intraoperative)
- Neonatal Apgar score at 1 min(1 min post delivery)
- Neonatal Apgar score at 5 min(5 min post delivery)
- neonatal blood gases(1 min post delivery)
- glucose in neonatal blood(1 min post delivery)
- incidence of hypertension(intraoperative)