- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00379691
Ideal Dose of Phenylephrine to Treat Low Blood Pressure During Cesarean Section
Phenylephrine Dose-Finding Study to Minimize Hypotension Due to Spinal Anesthesia for Cesarean Section
Study Overview
Detailed Description
The purpose of this study is to determine the minimum effective bolus dose of phenylephrine to prevent post-spinal hypotension in CS in 95 % of our patients. The study will be conducted in a randomized double-blinded fashion. This dose-response study will be conducted as per the up-down sequential allocation method, modified by the Narayana rule, designed to cluster the results around the ED95.
Blood pressure will be monitored every minute from intrathecal injection to the delivery of the child. Phenylephrine will be administered every time the blood pressure is equal to or lower than the control value.Hypotension will be defined as a SBP less than 80 % of the baseline value, in which case the treatment will be a failure. Hypertension will be defined as a SBP more than 120 % of baseline value. If a patient presents hypertension for two consecutive measurements, the case will be considered a drop out.An adequate response will be defined as the absence of hypotension or nausea/vomiting during the period from induction of spinal anesthesia to uterine incision prior to fetal delivery.
The results of this study will define the minimum effective dose of phenylephrine to prevent post-spinal hypotension and nausea/vomiting secondary to hypotension in Cesarean section, thus optimizing the safety profile with respect to maternal and fetal side effects of this vasopressor.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective CS 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
- Allergy or hypersensitivity to phenylephrine
- Preexisting or pregnancy-induced hypertension
- Cardiovascular or cerebrovascular disease
- Fetal abnormalities
- History of diabetes, excluding gestational diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome will be the minimum dose of phenylephrine which effectively prevents both hypotension and nausea/vomiting between intrathecal injection of the local anesthetic and delivery of the fetus.
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Secondary Outcome Measures
Outcome Measure |
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Maternal Demographics: Maternal age-weight-height
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Nausea and Vomiting
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Time of intrathecal injection, skin incision, uterine incision, and delivery
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Total dose of phenylephrine
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Hypertension (> 120 % of baseline)
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Bradycardia (< 50 bpm)
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Upper sensory level of anesthesia by pinprick upon delivery
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Umbilical artery and vein blood gases
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Collaborators and Investigators
Investigators
- Principal Investigator: Jose CA Carvalho, MD PhD, Department of Anesthesia and Pain Management, Mount Sinai Hospital, University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Signs and Symptoms, Digestive
- Nausea
- Hypotension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- 06-01
- 06-0186-E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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