Comparison of Different Noradrenaline Protocols to Prevent Post Spinal Hypotension During Elective Caesarean Delivery: A Randomised, Double-blind Clinical Trial
| Registry | NCT04701190 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 180 (Actual) |
| Sponsor | Ankara University (Other) |
| Conditions | Hypotension, Cesarean Section, Anesthesia, Spinal |
| Interventions | Noradrenalin 10 microgram bolus, Noradrenaline 5 microgram bolus, Noradrenaline 0.1 microgram/kg/minute infusion, Noradrenaline 0.05 microgram/kg/minute infusion, Infusion dosage: 0.075 microgram/kg/minute infusion, Spinal anesthesia (Drug, procedure) |
| Dates | start 2021-02-01, primary completion 2021-12-15, completion 2021-12-15, first posted 2021-01-08, last updated 2022-02-01 |
| Locations | 1 site in Turkey (Türkiye) |
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The incidence of hypotension after spinal anesthesia is approximately 60% in parturients undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and neurological deterioration in patients and low Apgar scores in newborns may occur. Therefore, there is an increasing interest to prevent maternal post spinal hypotension by using several drugs including noradrenaline given in different protocols to the patients undergoing spinal anesthesia for cesarean section. However, there is no conclusive answer to the question of which dosage is the best to prevent the maternal post spinal hypotension in literature.
In this prospective randomized study, we aimed to compare different noradrenaline protocols for preventing maternal post spinal hypotension during elective cesarean delivery.
One of the most important and frequent adverse effects of spinal anesthesia is post procedure hypotension. The emerging hypotension does not affect only the pregnant, it also does harm to the newborn. Therefore, an anesthesiologist should avoid and take precautions to prevent maternal post spinal hypotension. There is a growing body of evidence about noradrenalin application in the management of hemodynamic optimization of patients undergoing cesarean section with spinal anesthesia. However, there is no conclusive decision about the dosage and application protocol of noradrenaline in this patient population. In a study comparing the incidence of post spinal maternal hypotension given noradrenaline versus phenylephrine, the authors reported that both of drugs effectively controlled maternal blood pressure. The incidence of maternal hypotension was 30% and 32% (p= 0.8) in noradrenaline and phenylephrine study arms, respectively. Therefore, one can speculate that the incidence of maternal post spinal hypotension remains high even in patients receiving noradrenaline or phenylephrine. In the noradrenaline arm, only noradrenaline infusion with a dosage of 0.05 microgram/kg/minute without any bolus was applied to the patients. In another study, the effects of different noradrenaline infusion dosages with 5 microgram bolus dosage on maternal post spinal hypotension were investigated. The frequencies of maternal hypotension were 42.1%, 24.7% and 26% in patients receiving 0.025, 0.05 and 0.075 microgram/kg/minute with a bolus 5 microgram noradrenaline, respectively. As a conclusion of this study, addition of a bolus dose of 5 microgram noradrenaline may lower the incidence of post spinal hypotension. However, as in the previous study, approximately one fourth of patients still may have a post spinal hypotension episode. Regarding these results, the present study is planned to answer the question of which approach including increasing infusion or bolus dosage of noradrenaline is superior to ameliorate the incidence of hypotension in this population.
In conclusion, the aim of this study is to compare three different noradrenaline protocols including different bolus and infusion dosages to decrease the rate of hypotension in patients undergoing cesarean section with spinal anesthesia.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Noradrenaline 0.05/10 | Active comparator | Drug: Noradrenalin 10 microgram bolus; Drug: Noradrenaline 0.05 microgram/kg/minute infusion; Procedure: Spinal anesthesia | Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. |
| Noradrenaline 0.075/5 | Active comparator | Drug: Noradrenaline 5 microgram bolus; Drug: Infusion dosage: 0.075 microgram/kg/minute infusion; Procedure: Spinal anesthesia | Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. |
| Noradrenaline 0.1/0 | Active comparator | Drug: Noradrenaline 0.1 microgram/kg/minute infusion; Procedure: Spinal anesthesia | Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute without bolus dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. |
Sex: Female, ages: 18 Years to 40 Years
Inclusion Criteria: * ASA 2 * 38 +4 gestational age parturient Exclusion Criteria: * ASA 3-6 * Parturients with any kind of contraindication to spinal anesthesia * Hypertensive parturients (basal systolic blood pressure above 140 mmHg) * Parturients having basal systolic blood pressure below 100 mmHg * Parturients having peripartum hemorrhage * Parturients having body mass index above 40 * Parturients with a known allergic reaction to one of the study drugs * Parturients not willing to be included into the study
| Facility | City | Country | Status |
|---|---|---|---|
| Ankara University School of Medicine | Ankara | Turkey (Türkiye) |