Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00199784
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 22
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Phenylephrine	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia
• Study Start Date: Jun 1, 2005
• Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Differences in cardiac output []

2. Blood pressure []

3. Systemic vascular resistance []

Secondary Outcome Measures

1. Nausea []

2. Fatigue []

3. Cardiovascular instability due to overdosing spinal anesthesia for cesarean section (CS) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rikshospitalet-Radiumhospitalet HF	Oslo		Norway	0027

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Principal Investigator: Eldrid Langesæter, MD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00199784
• Other Study ID Numbers: Elangesectio2005-1; EudraCT2004-004902-26/S-05049
• First Posted: Sep 20, 2005
• Last Update Posted: Jul 6, 2011
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Hemodynamic; Hypotension; Spinal; Anesthesia; Healthy pregnant women for elective cesarean section
• Additional relevant MeSH terms: Phenylephrine; Oxymetazoline

Study Results

No Results Posted as of Jul 6, 2011