Best Regimen for Phenylephrine Administration During Cesarean Section

Phase 4

Completed

• Conditions: Cesarean Section; Cardiac Output; Hypotension
• Interventions: Drug: Phenylephrine

• Registration Number: NCT00996190
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2009-11
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine Intermittent Bolus	Phenylephrine	Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).
Phenylephrine Continuous Infusion	Phenylephrine	Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).

Primary Outcome Measures

Name	Time	Method
The maximum decrease in cardiac output in the pre-delivery period.	30 minutes

Secondary Outcome Measures

Name	Time	Method
Maximum decrease in heart rate in the pre-delivery period.	30 minutes
Incidence of hypotension in the pre-delivery period (BP < 80% baseline)	30 minutes
Incidence of hypertension in the pre-delivery period (BP > 120% baseline)	30 minutes
Incidence of nausea and vomiting in the pre-delivery period	30 minutes
Total dose of phenylephrine in the pre-delivery period	30 minutes
Umbilical artery and vein blood gases	24 hours

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada