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NCT00199784 Clinical Trial

Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

Healthy Clinical Trial

Official title:
Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00199784
Other study ID # Elangesectio2005-1
Secondary ID EudraCT2004-0049
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated July 3, 2011
Start date June 2005
Est. completion date April 2007

Study information
Verified date February 2009
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac output and systemic vascular resistance.

Description:

Hypotension during cesarean section with spinal anesthesia is common. We compare low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy pregnant women for elective cesarean section

Exclusion Criteria

- Shorter than 160 or taller than 180 cm

- Pre-pregnant body mass index (BMI) over 32

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Phenylephrine

Locations
Country Name City State
Norway Rikshospitalet-Radiumhospitalet HF Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or plac — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in cardiac output
Primary Blood pressure
Primary Systemic vascular resistance
Secondary Nausea
Secondary Fatigue
Secondary Cardiovascular instability due to overdosing spinal anesthesia for cesarean section (CS)
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