Evaluation of the efficacy of 6% hydroxyethyl starch (HES, 130/0.4) in normal saline compared to Ringer’s lactate solution for the prevention of hypotension during spinal anaesthesia for caesarean section - Caesar
- Conditions
- Prevention of maternal hypotension in patients undergoing spinal anaesthesia for caesarean section
- Registration Number
- EUCTR2007-006065-32-FR
- Lead Sponsor
- Fresenius Kabi Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 158
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method