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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.

Determination of the equivalent dose of phenylephrine and Akrinor in the prevention of post-spinal hypotension during Cesarean section.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-005617-13-BE
Enrollment
Unknown
Registered
2014-02-06
Start date
2014-05-27
Completion date
Unknown
Last updated
2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-spinal hypotension MedDRA version: 16.1 Level: LLT Classification code 10007532 Term: Cardiac complications of anesthesia or other sedation in labor and delivery System Organ Class: 100000004863

Interventions

Trade Name: Phenylephrine hydrochloride Product Name: phenylephrine hydrochloride Pharmaceutical Form: Injection INN or Proposed INN: PHENYLEPHRINE HYDROCHLORIDE CAS Number: 61-76-7 Concentration unit

Sponsors

University Hospitals Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - Pregnancy induced hypertension - Diabetes mellitus - Cardiovascular and cerebrovascular problems - Prenatally diagnosed foetal abnormalities - Contra-indications for spinal anesthesia - Active labour

Design outcomes

Primary

MeasureTime frame
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 - side effects of Akrinor and phenylephrine ;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

MeasureTime frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable—

Countries

Belgium

Contacts

Public ContactResearch anesthesiology

University Hospitals Leuven

christel.huygens@uzleuven.be32 16344270

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026