Skip to main content
OpenTrials
Completed

NCT Number: NCT00996190

Best Regimen for Phenylephrine Administration During Cesarean Section

During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. This low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.

Currently there are 2 methods of phenylephrine administration during Cesarean section. One method is by intermittent bolus and the other is by continuous infusion. It is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output.

In this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.

The hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Section Cardiac Output Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ability to communicate in English
  • Elective Cesarean Delivery under spinal anesthesia
  • Normal singleton pregnancy beyond 36 weeks gestation
  • ASA physical status I/II
  • Weight 50-100 kg, height 150-180 cm
  • Age over 18 years

Exclusion criteria

  • Patient refusal
  • Inability to communicate in English
  • Allergy or hypersensitivity to phenylephrine
  • Preexisting or pregnancy-induced hypertension
  • Cardiovascular or cerebrovascular disease
  • Fetal abnormalities
  • History of diabetes, excluding gestational diabetes
  • Contra-indications for spinal anesthesia

Treatment and study plan

Phenylephrine

Drug

phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose

Primary outcomes

  1. The maximum decrease in cardiac output in the pre-delivery period.

    Time frame: 30 minutes

Secondary outcomes

  1. Maximum decrease in heart rate in the pre-delivery period.

    Time frame: 30 minutes

  2. Incidence of hypotension in the pre-delivery period (BP < 80% baseline)

    Time frame: 30 minutes

  3. Incidence of hypertension in the pre-delivery period (BP > 120% baseline)

    Time frame: 30 minutes

  4. Incidence of nausea and vomiting in the pre-delivery period

    Time frame: 30 minutes

  5. Total dose of phenylephrine in the pre-delivery period

    Time frame: 30 minutes

  6. Umbilical artery and vein blood gases

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Study to Determine the Best Regimen for Administration of Phenylephrine During Spinal Anesthesia for Cesarean Delivery, as Determined by Maternal Blood Pressure and Cardiac Output

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 16, 2009
Registry last updated
Feb 23, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.