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Completed

NCT Number: NCT01967914

PVI for Prediction of Spinal Induced Hypotension

The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery

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Key information

Conditions

Spinal Induced Hypotension

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PVI

Other

Measurement of PVI (plethysmography variability index)

Primary outcomes

  1. 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

  1. 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

    Time frame: Intraoperative (approximately 2 hours)

    Correlation between PVI change in response to PLR and change in SBP and pulse rate (PR) from baseline, and need for vasopressors

  2. Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors.

    Time frame: Intraoperative (approximately 2 hours)

  3. Correlation between baseline PVI and need for vasopressors.

    Time frame: Intraoperative (approximately 2 hours)

  4. Correlation between baseline PVI and change in SBP and PR from baseline.

    Time frame: Intraoperative (approximately 2 hours)

  5. Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors

    Time frame: Intraoperative (approximately 2 hours)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2013
Registry last updated
Jun 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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