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.