Dataset Information

Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-Spinal Hypotension During Elective Caesarean Delivery: A Randomized, Controlled Trial.

ABSTRACT:

Background

Post-spinal hypotension is associated with maternal and neonatal complications; therefore, prompt control maternal blood pressure is necessary. In this study, we aimed to compare the efficacy and safety of two norepinephrine bolus doses in the rescue management of severe maternal hypotension during elective Cesarean delivery.

Methods

We included full-term pregnant women scheduled for Cesarean delivery under spinal anesthesia. Patients were randomized to receive either 5-mcg norepinephrine (n=79) or 10-mcg norepinephrine (n=79) for treatment of severe postspinal hypotension (systolic blood pressure ≤60% of baseline reading). The management of the hypotensive episode was considered successful if systolic blood pressure was >80% of the baseline within 2 mins of the bolus. The primary outcome was the incidence of successful management of severe post-spinal hypotension. Secondary outcomes included the incidence of reactive bradycardia, reactive hypertension, umbilical blood gases, and neonatal Apgar score at 5-min post-delivery.

Results

We included 73 patients in the 5-mcg group and 76 patients in the 10-mcg group into the final analysis. The incidence of successful management of severe hypotensive episodes was comparable between the two groups (43/73 [59%] and 46/76 [60%] in the 5-and 10-mcg group, respectively, P=0.917). The incidence of reactive hypertension, bradycardia, and neonatal outcomes were comparable between the two groups.

Conclusion

In mothers undergoing Cesarean delivery under spinal anesthesia, 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension. Furthermore, the incidence of reactive bradycardia and hypertension was comparable in the two doses.

Clinical trial registration

NCT05290740, URL: https://clinicaltrials.gov/ct2/show/NCT05290740.

SUBMITTER: Amin SM

PROVIDER: S-EPMC10804872 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-Spinal Hypotension During Elective Caesarean Delivery: A Randomized, Controlled Trial.

Amin Sarah M SM Hasanin Ahmed A Ghanem Nashwa Talaat NT Mostafa Maha M Elzayat Nashwa N Elsherbiny Mona M Abdelwahab Yaser Y

International journal of general medicine 20240119

<h4>Background</h4>Post-spinal hypotension is associated with maternal and neonatal complications; therefore, prompt control maternal blood pressure is necessary. In this study, we aimed to compare the efficacy and safety of two norepinephrine bolus doses in the rescue management of severe maternal hypotension during elective Cesarean delivery.<h4>Methods</h4>We included full-term pregnant women scheduled for Cesarean delivery under spinal anesthesia. Patients were randomized to receive either 5 ...[more]

PMID: 38264276

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Project description:BackgroundData on the best norepinephrine bolus dose for management of hypotension are limited. The aim of this study was to compare the efficacy and safety of two norepinephrine bolus doses in the rescue management of maternal hypotension during cesarean delivery.MethodsThis randomized, controlled trial included mothers scheduled for cesarean delivery with spinal anesthesia with a prophylactic norepinephrine infusion. Following spinal anaesthesia administration, a participant was considered hypotensive if systolic blood pressure was ≤80% compared to the baseline reading. Participants were allocated to receive either 6 mcg or 10 mcg norepinephrine bolus for the management of hypotensive episodes. The hemodynamic response after administration of norepinephrine bolus was recorded. The episode was considered successfully managed if systolic blood pressure returned to within 80% from the baseline reading within 2 min after norepinephrine bolus administration, and did not drop again within 6 min after the norepinephrine bolus. The primary outcome was the incidence of successful management of the first hypotensive episode. Other outcomes included systolic blood pressure, heart rate, incidence of maternal bradycardia, and reactive hypertension.ResultsOne hundred and ten mothers developed hypotensive episodes and received norepinephrine boluses for management. The number of successfully managed first hypotensive episodes was 50/57 (88%) in the 6 mcg-treated episodes and 45/53 (85%) in the 10 mcg-treated episodes (p = 0.78). Systolic blood pressure was comparable after administration of either bolus dose. Heart rate was lower after administration of 10 mcg bolus compared to 6 mcg bolus, without significant bradycardia requiring atropine administration. The incidence of reactive hypertension was comparable between both groups.ConclusionIn mothers undergoing elective cesarean delivery under prophylactic norepinephrine infusion at 0.05 mcg/kg/min, there was no advantage to the use of 10 mcg norepinephrine bolus over 6 mcg norepinephrine bolus for the rescue management of first hypotensive episode. Neither of the 2 bolus doses reached a 100% success rate. The incidences of bradycardia and reactive hypertension were comparable between both norepinephrine doses.Trial registrationAt clinicaltrial.gov registry system on January 4, 2019 Clinical trial identifier: NCT03792906.

Project description:BackgroundSpinal anaesthesia for caesarean section is the preferred technique since it provides better maternal safety and neonatal outcome compared to general anaesthesia. Hypotension is the most common complication after spinal anaesthesia. The study aims to determine the effectiveness of a prophylactic bolus dose of norepinephrine and ephedrine on the management of postspinal hypotension during caesarean section.MethodAn institutional-based prospective cohort study was conducted on 84 pregnant women undergoing elective caesarean section. Based on the responsible anaesthetist's postspinal hypotension management plan, patients were divided into two groups. Those patients who received ephedrine are grouped into the ephedrine (EPH, n = 42) group, and patients who received norepinephrine are grouped under the norepinephrine group (NE, n = 42) by data collectors. After aseptic technique, spinal anaesthesia was administered with 0.5% (3 ml) bupivacaine using a 23G spinal needle. During spinal anaesthesia, a prophylactic bolus dose of 10 mg (2 ml) EPH or 16 g (2 ml) NE was given based on management plan of the shift anaesthetist. Mean arterial pressure (MAP), the heart rate (HR), number of boluses of vasopressor used, incidence of nausea and vomiting, and the Apgar score of babies at 1 and 5 min between the groups were recorded.ResultsThe norepinephrine group had a statistically significant higher MAP compared to the ephedrine group in the first 10 and 15 min (p < 0.05) of the study period. Thereafter, there was no statistically significant difference in MAP between the groups until the end of the study period (p > 0.05). The ephedrine group had a statistically significant higher heart rate throughout the procedure compared to the norepinephrine group (p < 0.05). The norepinephrine group required a lower bolus number of vasopressors compared to the ephedrine group to maintain blood pressure. The Apgar scores of all babies at 1 and 5 min were above seven. Significant differences regarding maternal complications (nausea and vomiting) between the groups were not detected (nausea, p=0.21 and vomiting, p=0.092).ConclusionNorepinephrine can be used instead of ephedrine to keep a pregnant mother's blood pressure stable during a caesarean section under spinal anaesthesia without causing harm to the mother or baby. Trial registration. ClinicalTrials.gov Identifier: NCT05522088 (Date of registration: 30/08/22).

Project description:BackgroundFluid loading is one of the recognised measures to prevent hypotension due to spinal anaesthesia in women scheduled for a caesarean section.ObjectiveWe aimed to evaluate the current evidence on fluid loading in the prevention of spinal anaesthesia-induced hypotension.DesignSystematic review and network meta-analysis with trial sequential analysis and meta-regression.Data sourcesMedline, Epub, Embase.com (Embase and Medline), Cochrane Central, Web of Science and Google Scholar were used.Eligibility criteriaOnly randomised controlled trials were used. Patients included women undergoing elective caesarean section who received either crystalloid or colloid fluid therapy as a preload or coload. The comparator was a combination of either a different fluid or time of infusion.ResultsA total of 49 studies (4317 patients) were included. Network meta-analysis concluded that colloid coload and preload offered the highest chance of success (97 and 67%, respectively). Conventional meta-analysis showed that crystalloid preload is associated with a significantly higher incidence of maternal hypotension than colloid preload: risk ratio 1.48 (95% CI 1.29 to 1.69, P < 0.0001, I = 60%). However, this result was not supported by Trial Sequential Analysis. There was a significant dose-response effect for crystalloid volume preload (regression coefficient = -0.073), which was not present in the analysis of only double-blind studies. There was no dose-response effect for the other fluid regimes.ConclusionUnlike previous meta-analysies, we found a lack of data obviating an evidence-based recommendation. In most studies, vasopressors were not given prophylactically as is recommended. Studies on the best fluid regimen in combination with prophylactic vasopressors are needed. Due to official european usage restrictions on the most studied colloid (HES), we recommend crystalloid coload as the most appropriate fluid regimen.Trial registrationCRD42018099347.

Project description:Introduction: In this study, we aimed to evaluate the potential dose-response relationship between prophylactic norepinephrine (NE) infusion rates and the risks of hypotension during cesarean section following spinal anesthesia. Methods: Randomized controlled trials with two or more NE doses for post-spinal hypotension prophylaxis during cesarean section were systematically searched in the MEDLINE, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and US Clinical Trials Registry databases until 31 July 2022. The primary outcome was the relative risk of maternal hypotension with different NE regimens (infusion rates or bolus doses). Secondary outcomes included the relative risks of maternal and fetal adverse events with different NE regimens. Results: Ten studies with 1,144 parturients were included for final analysis using restricted cubic splines and random-effects dose-response meta-analysis models. A significant dose-response relationship existed between NE infusion rates and the relative risks of maternal hypotension. Every 0.01 μg/kg/min increment in the NE infusion rate was associated with a 14% decrease in the incidence of post-spinal hypotension. ED50 and ED95 of NE infusion rates for post-spinal hypotension prophylaxis were estimated to be 0.046 (95% CI from 0.032 to 0.085) and 0.2 (95% CI from 0.14 to 0.37) μg/kg/min, respectively. However, a higher NE infusion rate was associated with a higher incidence of maternal hypertension. Conclusion: An increased NE infusion rate was associated with a decreased incidence of post-spinal hypotension but an increased incidence of hypertension. Therefore, 0.07 μg/kg/min was recommended as the initial NE infusion rate for clinical practice, as it was associated with the lowest risk of physician intervention for unstable hemodynamics after spinal anesthesia for cesarean delivery. Systematic Review Registration: (https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=349934), identifier (CRD42022349934).

Project description:BackgroundThe OptiBIRTH study incorporates a multicentre cluster randomised trial in 15 hospital sites across three European countries. The trial was designed to test a complex intervention aimed at improving vaginal birth after caesarean section (VBAC) rates through increasing women's involvement in their care. Prior to developing a robust standardised model to conduct the health economic analysis, an analysis of a hypothetical cohort was performed to estimate the costs and health effects of VBAC compared to elective repeat caesarean delivery (ERCD) for low-risk women in four European countries.MethodsA decision-analytic model was developed to estimate the costs and the health effects, measured using Quality Adjusted Life Years (QALYs), of VBAC compared with ERCD. A cost-effectiveness analysis for the period from confirmation of pregnancy to 6 weeks postpartum was performed for short-term consequences and during lifetime for long-term consequences, based on a hypothetical cohort of 100,000 pregnant women in each of four different countries; Belgium, Germany, Ireland and Italy. A societal perspective was adopted. Where possible, transition probabilities, costs and health effects were adapted from national data obtained from the respective countries. Country-specific thresholds were used to determine the cost-effectiveness of VBAC compared to ERCD. Deterministic and probabilistic sensitivity analyses were conducted to examine the uncertainty of model assumptions.ResultsWithin a 6-week time horizon, VBAC resulted in a reduction in costs, ranging from €3,334,052 (Germany) to €66,162,379 (Ireland), and gains in QALYs ranging from 6399 (Italy) to 7561 (Germany) per 100,000 women birthing in each country. Compared to ERCD, VBAC is the dominant strategy in all four countries. Applying a lifetime horizon, VBAC is dominant compared to ERCD in all countries except for Germany (probabilistic analysis, ICER: €8609/QALY). In conclusion, compared to ERCD, VBAC remains cost-effective when using a lifetime time.ConclusionsIn all four countries, VBAC was cost-effective compared to ERCD for low-risk women. This is important for health service managers, economists and policy makers concerned with maximising health benefits within limited and constrained resources.

Dataset Information

Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-Spinal Hypotension During Elective Caesarean Delivery: A Randomized, Controlled Trial.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-Spinal Hypotension During Elective Caesarean Delivery: A Randomized, Controlled Trial.

Similar Datasets

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