Study to Detect Hypotensive Episodes During Spinal Anesthesia for Cesarean Section Using a Noninvasive Continuous Device

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: NCT01157520
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 9, 2010
Information provided by:
University of Schleswig-Holstein

Brief Summary:
Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. The investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures.

Condition or disease

Study Type : Observational
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hypotensive Episodes During Cesarean Section Detected by a Continuous Non-invasive Arterial Pressure Measurement Device Are Missed by the Oscillometric Blood Pressure Measurement
Study Start Date : June 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Women scheduled for elective Cesarean section under spinal anesthesia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
elective Cesarean section under spinal anesthesia

Inclusion Criteria:

  • ASA physical status I or II
  • week of pregnancy >36

Exclusion Criteria:

  • emergency cases Identifier: NCT01157520     History of Changes
Other Study ID Numbers: CNAP_Sectio
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 9, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents