Best Regimen for Phenylephrine Administration During Cesarean Section

Hypotension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996190
• Other study ID #: 09-03
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2009
• Last updated: February 22, 2011
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Output
• Cesarean Section
• Hypotension

Intervention

Drug:
• Phenylephrine
phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum decrease in cardiac output in the pre-delivery period.		30 minutes	No
Secondary	Maximum decrease in heart rate in the pre-delivery period.		30 minutes	No
Secondary	Incidence of hypotension in the pre-delivery period (BP < 80% baseline)		30 minutes	No
Secondary	Incidence of hypertension in the pre-delivery period (BP > 120% baseline)		30 minutes	No
Secondary	Incidence of nausea and vomiting in the pre-delivery period		30 minutes	No
Secondary	Total dose of phenylephrine in the pre-delivery period		30 minutes	No
Secondary	Umbilical artery and vein blood gases		24 hours	No