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Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jana Christine Kuhn, Anestesiavdelingen Baerum Sykehus
ClinicalTrials.gov Identifier:
NCT01278238
First received: January 14, 2011
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 Intervention
Caesarean Section
Drug: Phenylephrine
Device: Lower limb compression
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Anestesiavdelingen Baerum Sykehus:

Primary Outcome Measures:
  • Invasive arterial bloodpressure [ Time Frame: Until end of operation, up to roughly 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pH value from umbilical vessels of the newborn [ Time Frame: straight after delivery ] [ Designated as safety issue: No ]
  • APGAR score of the newborn [ Time Frame: 1 + 5 + 10 minutes after delivery ] [ Designated as safety issue: No ]
  • Need for rescue pressor (ephedrine, phenylephrine) [ Time Frame: Until end of operation, roughly 1 hour ] [ Designated as safety issue: No ]
  • Cardiac Output [ Time Frame: Until end of operation, roughly 1 hour ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278238

Locations
Norway
Bærum Sykehus
Rud, Akershus, Norway, 1309
Sponsors and Collaborators
Anestesiavdelingen Baerum Sykehus
Investigators
Principal Investigator: Jana Christine Kuhn, Dr.med. Bærum sykehus
  More Information

No publications provided

Responsible Party: Jana Christine Kuhn, Dr.med., Anestesiavdelingen Baerum Sykehus
ClinicalTrials.gov Identifier: NCT01278238     History of Changes
Other Study ID Numbers: 2009-013025-42
Study First Received: January 14, 2011
Last Updated: January 9, 2013
Health Authority: Norway: Statens Legemiddelverk
Norway: Regional Etisk Komite
Norway: Personvernombudet

Keywords provided by Anestesiavdelingen Baerum Sykehus:
Hypotension
Caesarean section
Spinal anaesthesia
Lower limb compression / wrapping
Phenylephrine

Additional relevant MeSH terms:
Anesthetics
Oxymetazoline
Phenylephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014