NCT01967914CompletedNot Applicable
Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Correlation between baseline PVI and change in SBP from baseline.
Study Overview
Brief Summary
The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
- •Scheduled or unscheduled cesarean delivery under spinal anesthesia
- •Height: 5 feet-5 feet 11 in.
Exclusion Criteria
- •Laboring women needing an emergency cesarean delivery
- •Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
- •Severe Cardiac disease in pregnancy with marked functional limitations
- •Diabetes type I
- •Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- •Inclusion in another anesthetic study involving drug administration.
Outcomes
Primary Outcomes
Correlation between baseline PVI and change in SBP from baseline.
Time Frame: Intraoperative (approximately 2 hours)
Correlation between baseline PVI and change in SBP from baseline.
Secondary Outcomes
- Correlation between plethysmography variability index (PVI) change in response to passive leg raising (PLR) and change in SBP and pulse rate (PR) from baseline, and need for vasopressors(Intraoperative (approximately 2 hours))
- Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors.(Intraoperative (approximately 2 hours))
- Correlation between baseline PVI and need for vasopressors.(Intraoperative (approximately 2 hours))
- Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors(Intraoperative (approximately 2 hours))
- Correlation between baseline PVI and change in SBP and PR from baseline.(Intraoperative (approximately 2 hours))
Investigators
Study Sites (1)
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