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Spinal anaesthesia is the anaesthetic technique of choice for elective caesarean delivery. Hypotension, a result of the decrease in systemic vascular resistance caused by spinal anaesthesia, is a frequent complication occurring in up to 80%. This study is to investigate fluid loading plus vasopressors to vasopressors alone to maintain stable maternal haemodynamics in elective caesarean delivery. The effect of the two methods (continuous prophylactic phenylephrine infusion with and without crystalloid co-loading) on maternal haemodynamics will be compared using the Starling SV Monitor. The Starling SV device is a non invasive cardiac output monitor (NICOM) which is certified and validated for the use in pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine infusion only | Active Comparator | Phenylephrine infusion only |
|
| Phenylephrine infusion and Ringer-Acetate bolus | Active Comparator | Phenylephrine infusion and Ringer-Acetate bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine infusion | Drug | continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in maternal cardiac output (CO) | CO measured by area under the curve (AUC) (L/min.) | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maternal heart rate | Change in maternal heart rate | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping |
| Change in maternal diastolic and systolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bigna Buddeberg, Dr. med | Department of Anaesthesiology, University Hospital of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, University Hospital of Basel (USB) | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38485584 | Derived | Buddeberg BS, Seeberger E, Blasi C, Dutilh G, Steiner LA, Bandschapp O, Palanisamy A, Girard T. Is crystalloid co-loading necessary to prevent spinal hypotension during elective cesarean delivery? A randomized double-blind trial. Int J Obstet Anesth. 2024 May;58:103968. doi: 10.1016/j.ijoa.2023.103968. Epub 2023 Dec 13. |
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double-blind, randomised controlled non-inferiority trial
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Investigator and participant cannot see to which study group the participant belongs. The person performing randomisation and fluid application will not be involved in the data collection and Analysis.
| Phenylephrine infusion and Ringer-Acetate bolus | Drug | continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure plus crystalloid Ringer-Acetate co-loading bolus of 1000 mL |
|
Change in maternal diastolic and systolic blood pressure (mmHg)
| measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping |
| incidence of maternal nausea | incidence of maternal Nausea (number) | measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping |
| Change in Apgar scores | The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration). | at 1 and 5 minutes after delivery |
| Change in umbilical cord pH | Change in umbilical cord pH | at 1 and 5 minutes after delivery |