Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery: a Double-blind, Randomised Controlled Trial Using the Non Invasive Cardiac Output Monitor StarlingTM SV.
Overview
- Phase
- Not Applicable
- Intervention
- Phenylephrine infusion
- Conditions
- Maternal Haemodynamic Stability
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change in maternal cardiac output (CO)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to give informed consent
- •Term uncomplicated singleton pregnancy
- •Undergoing elective caesarean section under spinal anaesthesia
- •Weight: 50-100kg
- •Height: 150-180cm
- •Healthy term fetus
Exclusion Criteria
- •Inability to give informed consent
- •Multiple pregnancy
- •Clinically significant concomitant disease states (e.g. hypertension, cardiac disease, severe asthma requiring regular medication, comorbidities affecting the autonomous nervous system, renal disease)
- •On any cardiovascular medication
- •Complications of pregnancy (e.g. preeclampsia, intrauterine growth restriction, fetal malformations)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
Arms & Interventions
Phenylephrine infusion only
Phenylephrine infusion only
Intervention: Phenylephrine infusion
Phenylephrine infusion and Ringer-Acetate bolus
Phenylephrine infusion and Ringer-Acetate bolus
Intervention: Phenylephrine infusion and Ringer-Acetate bolus
Outcomes
Primary Outcomes
Change in maternal cardiac output (CO)
Time Frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
CO measured by area under the curve (AUC) (L/min.)
Secondary Outcomes
- Change in maternal diastolic and systolic blood pressure(measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping)
- incidence of maternal nausea(measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping)
- Change in umbilical cord pH(at 1 and 5 minutes after delivery)
- Change in maternal heart rate(measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping)
- Change in Apgar scores(at 1 and 5 minutes after delivery)