Pregnancy, Cesarean Delivery, Hypotension
Conditions
Brief summary
The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.
Interventions
OTHERCrystalloid
Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
OTHERColloid
Patients will receive the rapid co-loading with 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.
Exclusion criteria
* multiple pregnancy * gestational age \< 36 weeks * preexisting or pregnancy-induced hypertension * Morbid cardiovascular impairments * Cerebrovascular disease ⑥ Known fetal anomaly ⑦ Contraindications to spinal anesthesia ⑧ Any sign of onset of labor ⑨ Body weight \< 45 kg or body weight \> 90 kg ⑩ Height \< 145cm or height \> 180cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of maternal hypotension | during the time period from induction of spinal anesthesia until delivery | defined as: Systolic Blood Pressure (SBP) \< 80% of baseline SBP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical arterial carbon dioxide partial pressure (PCO2) | immediately after delivery | carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg |
| incidence of severe hypotension | during the time period from induction of spinal anesthesia until delivery | defined as: Systolic Blood Pressure (SBP) \< 70% of baseline SBP |
| incidence of symptomatic hypotension | during the time period from induction of spinal anesthesia until delivery | defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness |
| incidence of bradycardia | during the time period from induction of spinal anesthesia until delivery | Heart Rate (HR) \<50 bpm |
| incidence of Hypertension | during the time period from induction of spinal anesthesia until delivery | Systolic Blood Pressure (SBP)\> 120% of baseline SBP |
| Minimum recorded Systolic Blood Pressure (Minimum SBP) | during the time period from induction of spinal anesthesia until delivery | The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery |
| Minimum recorded Heart Rate (Minimum HR) | during the time period from induction of spinal anesthesia until delivery | The lowest recorded HR during the time period from induction of spinal anesthesia until delivery |
| Cumulative duration of hypotension | during the time period from induction of spinal anesthesia until delivery | duration of hypotension, minutes |
| Onset time of hypotension | during the time period from induction of spinal anesthesia until delivery | Time from the induction of spinal anesthesia until the first event of hypotension occur |
| Umbilical arterial partial oxygen pressure (PO2) | immediately after delivery | partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg |
| Rescue phenylephrine use | during the time period from induction of spinal anesthesia until delivery | number of patients who require the rescue use of phenylephrine |
| Rescue ephedrine use | during the time period from induction of spinal anesthesia until delivery | number of patients who require the rescue use of ephedrine |
| Atropine use | during the time period from induction of spinal anesthesia until delivery | number of patients who require the rescue use of atropine |
| Incidence of nausea, vomiting | during the time period from induction of spinal anesthesia until delivery | The incidence of nausea, vomiting |
| Incidence of dizziness, breathlessness | during the time period from induction of spinal anesthesia until delivery | The incidence of dizziness, breathlessness |
| Cutaneous stellate ganglion sympathetic activity | during the time period from induction of spinal anesthesia until delivery | noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes |
| Apgar Score, 1 min, 5 min (fetal outcome) | 1 min, 5 min after delivery | Apgar Score of delivered baby. 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 the Appearance, Pulse, Grimace, Activity, and Respiration. Each is scored on a scale of 0 to 2, with 2 being the best score. The test is done at 1 and 5 minutes after birth. |
| Umbilical arterial pH | immediately after delivery | pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome) |
| Umbilical arterial base excess | immediately after delivery | base excess of Umbilical ABGA (fetal outcome), mmol/L |
| Total phenylephrine use | during the time period from induction of spinal anesthesia until delivery | Cumulative dose of phenylephrine administered via continuous infusion, mcg |
Countries
South Korea
Outcome results
None listed