Cesarean Section Complications, Spinal Anesthesia
Conditions
Keywords
cesarean section complications, spinal anesthesia, norepinephrine, maternal hemodynamic and cardiac output
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).
Interventions
DRUGNorepinephrine
Drug: Norepinephrine Norepinephrine tartrate variable infusion with a starting rate of 0,1μg/kg/min (equivalent to norepinephrine base of 0.05 μg /Kg/min). Other name: Noradrenaline Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg
DRUGPhenylephrine
Drug: Phenylephrine variable infusion with a starting rate of 0,5μg/kg/min Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | From induction of spinal anesthesia until weaning of vasopressor | number of heart beats per minute |
| 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 |
| 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 |
| 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 |
| Cardiac Output | after applying spinal anesthesia until weaning of vasopressor | Measured in L/min |
| 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 |
| Maximum flow rate of study drug given | after applying spinal anesthesia until weaning of vasopressor | Measured in mcg/hour |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| Maternal blood glucose concentration | at peripheral intravenous line placement | concentration measured in mmol/l |
| APGAR score | 1 minute after delivery | APGAR score of the fetus ranging from 0 to 10 |
| Umbilical arterial potential hydrogen | At time of birth | potential hydrogen in the blood sample obtained from umbilical artery scaled from 1 to 14 |
| Fetal lactates | At time of birth | from umbilical artery blood sample, 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 |
| Umbilical arterial partial pressure of oxygen | At time of birth | in the blood sample obtained from umbilical artery measured in mmHg |
| Umbilical arterial base excess | At time of birth | in the blood sample obtained from umbilical artery measured in mmol/L |
| 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 before realization of spinal anesthesia | pulsatility index of Gosling (peak systolic velocity - end diastolic velocity /mean velocity) |
Countries
France
Outcome results
None listed