Best Regimen for Phenylephrine Administration During Cesarean Section

NCT ID: NCT00996190

Last Updated: 2011-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-08-31

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.

Conditions

Cesarean Section; Cardiac Output; Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phenylephrine Intermittent Bolus

Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution).

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: DRUG

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

Phenylephrine Continuous Infusion

Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution).

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: DRUG

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

Interventions

Phenylephrine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mount Sinai Hospital

Principal Investigators

Jose Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

09-03

Identifier Type: -

Identifier Source: org_study_id