A study to determine the dose of Akrinor that is equally efficient as phenylephrine in the prevention of blood pressure decrease after anesthaesia in patients undergoing a Cesarean section.
- Conditions
- post-spinal hypotensionMedDRA version: 16.1Level: LLTClassification code 10007532Term: Cardiac complications of anesthesia or other sedation in labor and deliverySystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2013-005617-13-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Elective Cesarean section
- Singleton pregnancies
- >36 weeks
- >18 years
- ASA 1-2
- 50-120 kg
- 150-180 cm
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Pregnancy induced hypertension
- Diabetes mellitus
- Cardiovascular and cerebrovascular problems
- Prenatally diagnosed foetal abnormalities
- Contra-indications for spinal anesthesia
- Active labour
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To find the equipotent dose for Akinor compared to phenylephrine in the treatment of spinal induced hypotension for elective Cesarean section.;Secondary Objective: not applicable.;Primary end point(s): - dose at which Akrinor is equally efficient as phenylephrine<br>- side effects of Akrinor and phenylephrine<br>;Timepoint(s) of evaluation of this end point: every 5 min from the start of the spinal-epidural procedures until delivery of the babe or 30 min after intrathecal injection, whichever comes first, then every 15 min until the patients leaves the recovery romm
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable