Dataset Information

Treatment of spinal anaesthesia-induced hypotension with cafedrine/theodrenaline versus ephedrine during caesarean section: Results from HYPOTENS, a national, multicentre, prospective, noninterventional study.

ABSTRACT:

Background

In Germany, hypotension induced by spinal anaesthesia is commonly treated with a combination of cafedrine hydrochloride (C, 200 mg) and theodrenaline hydrochloride (T, 10 mg) in 2 ml. We compared the effectiveness of C/T with ephedrine.

Objectives

The primary objectives were to assess the speed of onset and the ability to restore blood pressure without an increase in heart rate. Secondary objectives were to evaluate maternal/foetal outcomes and the number of required additional boluses or other additional measures.

Design

HYPOTENS was a national, multicentre, prospective, open-label, two-armed, noninterventional study comparing C/T with ephedrine in two prospectively defined cohorts. This study relates to the cohort of patients receiving spinal anaesthesia for caesarean section.

Setting

German hospitals using either C/T or ephedrine in their routine clinical practice.

Patients

Women aged at least 18 years receiving spinal anaesthesia for caesarean section.

Interventions

Bolus administration of C/T or ephedrine at the discretion of the attending anaesthesiologist.

Main outcome measures

Endpoints within 15 min after initial administration of C/T or ephedrine were area under the curve between the observed SBP and the minimum target SBP; and incidence of newly occurring heart rate of at least 100 beats min-1.

Results

Although effective blood pressure stabilisation was achieved with both treatments, this effect was faster and more pronounced with C/T (P < 0.0001). The incidence of tachycardia and changes in heart rate were higher with ephedrine (P < 0.01). Fewer additional boluses (P < 0.01) were required with C/T. Although favourable neonatal outcomes were reported in both groups, base deficit and lactate values were greater with ephedrine (P < 0.01). Physician satisfaction was higher with C/T.

Conclusions

After C/T, tachycardia was not a problem, providing an advantage over ephedrine. Fewer additional boluses were required with C/T, suggesting greater effectiveness. An increased base deficit with ephedrine suggests reduced oxygen supply or increased demands in foetal circulation.

Trials registration

Clinicaltrials.gov: NCT02893241, German Clinical Trials Register: DRKS00010740.

SUBMITTER: Kranke P

PROVIDER: S-EPMC8452326 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundSympathomimetic drugs are a therapeutic cornerstone for the management of hypotensive states like intraoperative hypotension (IOH). While cafedrine/theodrenaline (C/T) is widely used in Germany to restore blood pressure in patients with IOH, more research is required to compare its effectiveness with alternatives such as ephedrine (E) that are more commonly available internationally.MethodsHYPOTENS (NCT02893241, DRKS00010740) was a prospective, national, multicenter, open-label, two-armed, non-interventional study that compared C/T with E for treatment of IOH. We describe a prospectively defined cohort of patients ≥50 years old with comorbidities undergoing general anesthesia induced with propofol and fentanyl. Primary objectives were to examine treatment precision, rapidity of onset and the ability to restore blood pressure without relevant increases in heart rate. Secondary endpoints were treatment satisfaction and the number of required additional boluses or other accompanying measures.ResultsA total of 1496 patients were included in the per protocol analysis. Overall, effective stabilization of blood pressure was achieved with both C/T and E. Post-hoc analysis showed that blood pressure increase from baseline was more pronounced with C/T. Fewer additional boluses or other accompanying measures were required in the C/T arm. The incidence of tachycardia was comparable between groups. Post-hoc analysis showed that E produced dose-dependent elevated heart rate values. By contrast, heart rate remained stable in patients treated with C/T. Physicians reported a higher level of treatment satisfaction with C/T, with a higher proportion of anesthetists rating treatment precision and rapidity of onset as good or very good when compared with E.ConclusionNeither drug was superior in restoring blood pressure levels; however, post-hoc analyses suggested that treatment is more goal-orientated and easier to control with C/T. Heart rate was shown to be more stable with C/T and fewer additional interventions were required to restore blood pressure, which could have contributed to the increased treatment satisfaction reported by anesthetists using C/T.

Project description:IntroductionIn general, caesarean sections are performed under spinal anaesthesia. Hypotension after spinal anaesthesia adversely affects both the mother and fetus. Although several studies have used pulse oximetry-derived indices, such as pulse perfusion index (PI) and Pleth variability index (PVI), to predict hypotension after spinal anaesthesia, the predictive ability of the PI and PVI remain controversial.Methods and analysisWe prepared this protocol following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will conduct searches of MEDLINE, Embase, Web of Science, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Clinicaltrial.gov, European Union Clinical Trials Register (EU-CTR), WHO International Clinical Trials Registry Platform (ICTRP) and University Hospital Medical Information Network Clinical Trials Registry (UMIN) from inception until 8 October 2022. We will include retrospective and prospective observational studies and randomised controlled trials that evaluated the predictive ability of PI and PVI for hypotension after spinal anaesthesia for caesarean section, published in any language. We will exclude case reports, case series and animal studies. Two authors will independently scan and select eligible studies and perform data extraction and assessment of risk of bias. We will estimate predictive ability of PI and PVI as indices of hypotension after spinal anaesthesia for caesarean section using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve. We will assess the quality of evidence using the Grading of Recommendation Assessment, Development and Evaluation approach.Ethics and disseminationEthics approval is not required as the systematic review will use existing published data. The results will be submitted for publication in a peer-reviewed journal.Prospero registration numberCRD42022362596.

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:Background: Obesity, abdominal surgery, and intrathecal opioids are all factors associated with a risk for respiratory compromise. The aim of this explorative trial was to study the apnoea/hypopnea index 1st postoperative night in obese mothers having had caesarean section (CS) in spinal anaesthesia with a combination of bupivacaine/morphine and fentanyl. Methods: Consecutive obese (BMI >30 kg/m 2) mothers, ≥18 years, scheduled for CS with bupivacaine/morphine/fentanyl spinal anaesthesia were monitored with a portable polygraphy device Embletta /NOX on 1 st postoperative night. The apnoea/hypopnea index (AHI) was identified by clinical algorithm and assessed in accordance to general guidelines; number of apnoea/hypopnea episodes per hour: <5 "normal", ≥5 and <15 mild sleep apnoea, ≥15 and <30 moderate sleep apnoea, ≥ 30 severe sleep apnoea. Oxygen desaturation events were in similar manner calculated per hour as oxygen desaturation index (ODI). Results: Forty mothers were invited to participate: 27 consented, 23 were included, but polysomnography registration failed in 3. Among the 20 mothers studied: 11 had an AHI <5 ( normal), 7 mothers had AHI ≥5 but <15 ( mild OSAS) and 2 mothers had AHI ≥15 ( moderate OSA), none had an AHI ≥ 30. The ODI was on average 4.4, and eight patients had an ODI >5. Mothers with a high AHI (15.3 and 18.2) did not show high ODI. Mean saturation was 94% (91-96%), and four mothers had mean SpO 2 90-94%, none had a mean SpO2 <90%. Conclusion: Respiratory polygraphy 1 st night after caesarean section in spinal anaesthesia with morphine in moderately obese mothers showed AHIs that in sleep medicine terms are considered normal, mild and moderate. Obstructive events and episodes of desaturation were commonly not synchronised. Further studies looking at preoperative screening for sleep apnoea in obese mothers are warranted but early postop respiratory polygraphy recording is cumbersome and provided sparse important information.