Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278238
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : January 11, 2013
Information provided by (Responsible Party):
Jana Christine Kuhn, Anestesiavdelingen Baerum Sykehus

Brief Summary:

The purpose of this study is to determine wether intravenous Phenylephrine, administered as start bolus and following continuous infusion (specific dosage per weight), or optimal lower limb bandaging is more effective in preventing hypotension during caesarean section under spinal anaesthesia in healthy women.

The hypothesis is that the Phenylephrine model is superior to lower limb compression in preventing hypotension.

Condition or disease Intervention/treatment Phase
Caesarean Section Drug: Phenylephrine Device: Lower limb compression Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hemodynamic Effect of Prophylactic Phenylephrine Versus Lower Limb Compression in Women During Caesarean Section Under Spinal Anaesthesia
Study Start Date : January 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Active Comparator: Phenylephrine Drug: Phenylephrine
Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min

Active Comparator: Lower limb compression Device: Lower limb compression
Tight bandaging of lower extremity up to hips with compression bandages

Placebo Comparator: Placebo Other: Placebo
Neither phenylephrine nor lower limb bandaging

Primary Outcome Measures :
  1. Invasive arterial bloodpressure [ Time Frame: Until end of operation, up to roughly 1 hour ]

Secondary Outcome Measures :
  1. pH value from umbilical vessels of the newborn [ Time Frame: straight after delivery ]
  2. APGAR score of the newborn [ Time Frame: 1 + 5 + 10 minutes after delivery ]
  3. Need for rescue pressor (ephedrine, phenylephrine) [ Time Frame: Until end of operation, roughly 1 hour ]
  4. Cardiac Output [ Time Frame: Until end of operation, roughly 1 hour ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Healthy women Elective caesarean section under spinal anaesthesia Informed consent Age 18-40 ASA 1-2 BMI 18-32 prior to pregnancy Height 160-180 cm

Exclusion Criteria:

Any form of disease or anomalities:

Heart or vascular disease Cerebrovascular disease Other somatic or psychiatric disease Hypertension or preeclampsia Contraindication against spinal anaesthesia Anomalities concerning pregnancy and foster

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278238

Bærum Sykehus
Rud, Akershus, Norway, 1309
Sponsors and Collaborators
Anestesiavdelingen Baerum Sykehus
Principal Investigator: Jana Christine Kuhn, Bærum sykehus

Responsible Party: Jana Christine Kuhn,, Anestesiavdelingen Baerum Sykehus Identifier: NCT01278238     History of Changes
Other Study ID Numbers: 2009-013025-42
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Jana Christine Kuhn, Anestesiavdelingen Baerum Sykehus:
Caesarean section
Spinal anaesthesia
Lower limb compression / wrapping

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents