Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia
- Conditions
- Spinal AnesthesiaCesarean Section Complications
- Interventions
- Registration Number
- NCT03849508
- Lead Sponsor
- Centre Hospitalier Régional d'Orléans
- Brief Summary
Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery.
- Detailed Description
Maternal hypotension is a frequent complication after spinal anesthesia for cesarean delivery. Many vasopressors have been studied and used, but the perfect vasopressor is yet to be found. Phenylephrine is the most common used in obstetric anesthesia but its cardiac depressant activity, being an only alpha-adrenergic agonistic, is linked to frequent side effects such as bradycardia and decreased cardiac output.
Norepinephrine is a vasopressor characterized by both alpha and minor beta-adrenergic agonistic activity, it has then a minimal cardiac depressant activity. Hence it would provide a better stability of hemodynamic and cardiac output, and appears as a better alternative to phenylephrine.
In this study, the investigators will compare prophylactic continuous variable infusion of both vasopressors. Phenylephrine started at the dose of 0,5mcg/kg/min and Norepinephrine tartrate started at the dose of 0,1mcg/kg/min. The doses will be adjusted according to maternal systolic blood pressure in order to prevent hypotension (defined by a systolic blood pressure under 80% of baseline).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 124
- Pregnancy higher than 36 weeks of amenorrhea
- Scheduled or semi-urgent (interval between decision and delivery by cesarean section higher than 12hours) cesarean section under spinal anesthesia
- Extreme height (less than 140cm; higher than 180cm)
- Weight less than 50kg
- Weight higher than 120kg
- Cardiovascular disease with use of cardiac medication (including antihypertensive drug)
- Active neurological disease
- Anti-hypertension treatment.
- High blood pressure or severe pre-eclampsia
- American Society of Anesthesiologists physical status class higher than 3
- Placenta accrete/percreta
- Cesarean section scheduled under general anesthesia
- Contraindications to spinal anesthesia
- Minor (age less than 18 years old)
- Guardianship/ curatorship
- Anemia less than or equal to 8 g/dl
- Allergy to any study medication
- Simultaneous participation in another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Norepinephrine Norepinephrine Spinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of norepinephrine tartrate started at an initial rate of 0,1mcg/kg/min. The rate will be adjusted according to maternal systolic blood pressure. phenylephrine Phenylephrine Spinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of phenylephrine started at an initial rate of 0,5mcg/kg/ min. The rate will be adjusted according to maternal systolic blood pressure.
- Primary Outcome Measures
Name Time Method Cardiac output maintenance (measured in L/min by bioreactance). 5 minutes before the induction of spinal anesthesia until umbilical cord clamping. Cardiac output values were analyses at eight points
* Baseline measurement: patient placed in the supine position with the table tilted 10° left, before spinal anesthesia
* Seven measurements at regular intervals: first measurement just after administration of spinal anesthesia in supine position with the table tilted 10° left and last measurement at umbilical cord clamping.
- Secondary Outcome Measures
Name Time Method Systolic blood pressure From induction of spinal anesthesia until weaning of vasopressor Systolic blood pressure measured in mmHg
Mean blood pressure From induction of spinal anesthesia until weaning of vasopressor Mean blood pressure measured in mmHg
Cardiac Output after applying spinal anesthesia until weaning of vasopressor Measured in L/min
Fetal lactates At time of birth from umbilical artery blood sample, measured in mmol/l
Heart rate From induction of spinal anesthesia until weaning of vasopressor number of heart beats per minute
Duration of bradycardia From induction of spinal anesthesia until weaning of vasopressor] Cumulative time in minutes with heart rate less than 60 beats/min
Duration of hypotension with Mean blood pressure less than 65mmHg after applying spinal anesthesia until weaning of vasopressor Cumulative time in minutes
Total dose of study drug consumed after applying spinal anesthesia until weaning of vasopressor Total dose of study drug given from induction of spinal anesthesia to delivery of the fetus
Incidence of nausea or vomiting after applying spinal anesthesia until weaning of vasopressor The percentage of patients with nausea or vomiting (at least one episode)
APGAR score 10 minutes after delivery APGAR score of the fetus ranging from 0 to 10
Umbilical arterial partial pressure of oxygen At time of birth in the blood sample obtained from umbilical artery measured in mmHg
Duration of hypotension with Systolic Blood Pressure less than 80mmHg after applying spinal anesthesia until weaning of vasopressor Cumulative time in minutes
Duration of hypertension after applying spinal anesthesia until weaning of vasopressor Cumulative time in minutes with Systolic Blood Pressure more than 140mmHg
Stroke Volume after applying spinal anesthesia until weaning of vasopressor Measured in ml/beat
Total Peripheral Resistance after applying spinal anesthesia until weaning of vasopressor Measured in dynes.sec.cm-5
Total Rescue Bolus Dose of atropine to maintain Systolic Blood Pressure after applying spinal anesthesia until weaning of vasopressor Total dose of atropine administered (mg)
Umbilical arterial base excess At time of birth in the blood sample obtained from umbilical artery measured in mmol/L
Maximum flow rate of study drug given after applying spinal anesthesia until weaning of vasopressor Measured in mcg/hour
Total Rescue Bolus Dose of ephedrine or other vasopressor to maintain Systolic Blood Pressure after applying spinal anesthesia until weaning of vasopressor Total dose of ephedrine or other vasopressor administered (mg)
Maternal blood glucose concentration at umbilical cord clamping concentration measured in mmol/l
Umbilical arterial partial pressure of carbon dioxide At time of birth in the blood sample obtained from umbilical artery measured in mmHg
Fetal blood glucose concentration at birth At time of birth from umbilical artery blood sample, measured in mmol/l
Neonatal blood glucose concentration at 1 hour after birth Capillary blood glucose is measured in mmol/l
Uterine and umbilical arteries Doppler with measurement of the pulsatility 5 minutes after induction of spinal anesthesia pulsatility index of Gosling (peak systolic velocity - end diastolic velocity /mean velocity)
Incidence of dizziness or malaise after applying spinal anesthesia until weaning of vasopressor The percentage of patients with dizziness or malaise (at least one episode)
Umbilical arterial potential hydrogen At time of birth potential hydrogen in the blood sample obtained from umbilical artery scaled from 1 to 14
Trial Locations
- Locations (1)
Regional Hospital Center of ORLEANS
🇫🇷Orléans, France