Prevention of maternal hypotension in patients undergoing spinal anaesthesia for caesarean section
Conditions
Interventions
Trade Name: Voluven, solution for infusion
Product Name: Voluven, solution for infusion
Pharmaceutical Form: Solution for infusion
Trade Name: Ringer Lactate Fresenius, solution for infusion
Product
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women undergoing elective caesarean section applying spinal anaesthesia 2. Women = week 37 of gestation 3. Singleton pregnancy 4. Age = 18 years 5. ASA I or II 6. Women in good health 7. Body weight = 60 kg and = 95 kg 8. Willingness to participate as indicated by a written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindication to spinal anaesthesia 2. Suspicion of any hypertensive disease 3. Diabetes mellitus 4. Heart disease 5. History of coagulation disorders 6. Parturient in labour 7. Signs or symptoms of foetal distress 8. Women carrying a foetus with a known abnormality 9. Any other volume substitution than study medication prior induction of spinal anaesthesia 10. Fluid overload (hyperhydration), especially in case of pulmonary oedema and congestive cardiac failure 11. Renal failure with oliguria or anuria 12. Hyperkalaemia 13. Hypercalcemia 14. Alkalosis 15. Patients receiving dialyses treatment 16. Intracranial bleeding 17. Known or suspected hypersensitivity to the study medication 18. Known contraindication against scheduled concomitant medication 19. Participation in another clinical study within the last four weeks 20. Patients with psychiatric diseases, epilepsy 21. Suspicion of drug- or alcohol abuse 22. Patients unable to co-operate adequately
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate superiority of HES 130/0.4 (6%) in saline with regard to the incidence of hypotension between induction of spinal an-aesthesia and delivery. ;Secondary Objective: Secondary parameters for exploratory analysis are defined as: Minimum systolic blood pressure until delivery, maternal heart rate, time and duration of hypotension, total Phenylephrine requirements until delivery, laboratory pa-rameters, outcome for the infant, and Adverse Events.;Primary end point(s): The incidence of hypotension between induction of spinal anaesthesia and delivery. Hypotension is defined as a decrease of systolic blood pressure below 80% of base-line value. | — |
Countries
France
Outcome results
None listed