Anesthesia; Adverse Effect, Spinal and Epidural, Hypotension
Conditions
Keywords
colloid preloading, colloid coloading
Brief summary
The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
Detailed description
Spinal anesthesia (SA) is currently the most preferred method of anesthesia in elective cesarean deliveries. However, SA causes maternal hypotension by decreasing systemic vascular resistance over sympathetic blockade. Maternal hypotension can lead to serious adverse events both in mother and in fetus: fetal hypoxia and acidosis occur due to decreased uterine blood flow, whereas the mother may experience vertigo, nausea, vomiting, alteration in consciousness, cardiovascular collapse and arrest. Today, various strategies have been suggested for the prevention of maternal hypotension. Of these strategies, the most critical ones are fluid load before spinal anesthesia (preloading) or rapid fluid load just after spinal anesthesia (coloading) and the use of vasopressor agent. The fluids used for this purpose include crystalloids and colloids. Comparative studies performed with colloid preloading, colloid coloading and crystalloid coloading indicated that the incidence of hypotension decreased similarly with no significant difference determined between the methods of fluid loading. Researchers defended necessity of using vasopressor agent together with fluid loading methods. In daily routine; however, the investigators observe that the incidence of hypotension is lower in the patients that undergo colloid preloading as compared to the patients that undergo colloid coloading or crystalloid coloading. The investigators therefore aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. In the present study, the investigators aimed to use 6% HES 130/0.4 (Voluven ®), which is the newer generation colloid solution. The other aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.
Interventions
DRUGhydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)
Before spinal anesthesia
DRUGhydroxyethyl starch (%6 HES 130/0.4) (Voluven®)
Just after spinal anesthesia
Sponsors
Sifa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older * Singleton pregnancy * Gestational age ≥ 37 weeks * Height ≥ 150 cm and ≤ 180 cm * Weight \> 50 kg and \< 100 kg
Exclusion criteria
* Gestational age \> 37 weeks * Multiple pregnancies * Fetal distress * Preeclampsia * Cardiovascular disease and diabetes * Hematological problems * Local infection at intervention site * Abnormal coagulation tests * Anticoagulant use * Starch allergy * Height \< 150 cm and \> 180 cm * Weight \< 50 kg and \> 100 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative duration of hypotension. | Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days. | Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping). |
| Incidence of severe hypotension. | Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days. | Incidence of severe hypotension (SAP \< 70% of the baseline value or SAP \< 80 mmHg) will be recorded. |
| Maternal hypotension. | Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days. | Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter. |
| Heart rate. | Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days. | Minimum and maximum heart rate, bradycardia, atropine usage will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea and/or vomiting. | Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days. | Incidence of nausea and/or vomiting, incidence of prepartum nausea and/or vomiting will be recorded. |
| Neonatal effects. | Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days. | Arterial and venous blood gas analyses will be performed from the umbilical cord after the cord clamped. |
| Ephedrine treatment. | Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days. | If SAB \< 100 mmHg; patients will be treated by 5 mg IV bolus ephedrine, if SAB \< 90 mmHg; patients will be treated by 10 mg IV bolus ephedrine. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preoperative fasting period. | Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days. | preoperative fasting period will be recorded. |
| Durations of anesthesia and surgery. | Time between induction of spinal anesthesia until end of the anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days. | Time period from induction of spinal anesthesia to skin incision (min), time period from induction of spinal anesthesia to delivery (min), time period from uterine incision to birth (sec), duration of anesthesia (min), and duration of surgery (min) will be recorded. |
| Preoperative hemoglobin concentration (g/dL). | Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days. | Before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAysun Afife Kar, MD
Outcome results
None listed