Best Regimen for Phenylephrine Administration During Cesarean Section

NCT00996190 | Completed Phase 4

• 1 other identifier: 09-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

transthoracic bioreactance; noninvasive monitoring; vasopressor; blood pressure

Outcome Measures

Primary Outcomes (1)

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

  30 minutes

Secondary Outcomes (6)

• 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

Study Arms (2)

Phenylephrine Intermittent Bolus

ACTIVE COMPARATOR

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

Drug: Phenylephrine

Phenylephrine Continuous Infusion

ACTIVE COMPARATOR

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

Drug: Phenylephrine

Interventions

Phenylephrine DRUG

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

Phenylephrine Continuous Infusion; Phenylephrine Intermittent Bolus

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Jose Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: November 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 23, 2011

Record last verified: 2011-02

Locations

CA (1)