- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02962986
A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries
A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries: a Randomized Controlled Study
Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and can have unwanted side effects on both mother and fetus if not treated promptly. Phenylephrine has been the drug of choice to treat this spinal-induced hypotension. Although phenylephrine is safe to use for this indication, it has been associated with reflex bradycardia and a reduction in cardiac output.
Norepinephrine is a potent vasopressor used to treat hypotension in the critical care setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and have shown that it can be used safely and also has favourable hemodynamic properties when compared to phenylephrine, with less bradycardia and less depression of cardiac output.
The investigators recently conducted a study to determine the ED90 of norepinephrine, and now plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension following spinal anesthesia for cesarean section.
The investigators hypothesize that norepinephrine, when given as a bolus to prevent post spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia when compared to phenylephrine in patients undergoing elective cesarean delivery under spinal anesthesia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X5
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Informed consent
- Elective CS under spinal anesthesia
- Normal singleton pregnancy beyond 36 weeks gestation
- ASA physical status 2-3
- Current (pregnant) 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
- Allergy or hypersensitivity to sulfite
- Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
- Untreated hyperthyroid patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: norepinephrine 6mcg
norepinephrine, given as 1mL IV boluses, to treat post-spinal hypotension
|
Norepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL
Other Names:
|
Active Comparator: phenylephrine 100mcg
phenylephrine, given as 1mL IV boluses, to treat post-spinal hypotension
|
Phenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bradycardia: Heart rate less than 50 bpm
Time Frame: 30 minutes
|
Heart rate less than 50 bpm, from induction of spinal anesthesia
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of vomiting
Time Frame: 30 minutes
|
Presence of vomiting in patients from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Hypotension: Systolic blood pressure less than 80% of baseline
Time Frame: 30 minutes
|
Systolic blood pressure below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Number of hypotensive episodes
Time Frame: 30 minutes
|
The number of times the systolic blood pressure measures below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Hypertension: Systolic blood pressure at or above 120% of baseline
Time Frame: 30 minutes
|
Systolic blood pressure at or above 120% of baseline, from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Tachycardia: Heart rate greater than 30% of baseline
Time Frame: 30 minutes
|
Heart rate greater than 30%, from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Presence of nausea
Time Frame: 30 minutes
|
Presence of nausea in patients from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Number of episodes of nausea
Time Frame: 30 minutes
|
The number of episodes of nausea experienced by patients from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Number of episodes of vomiting
Time Frame: 30 minutes
|
The number of episodes of vomiting experienced by patients from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Total dose of study drug given
Time Frame: 30 minutes
|
Total dose of study drug given from induction of spinal anesthesia to delivery of the fetus.
|
30 minutes
|
Apgar scores
Time Frame: 1 minute and 5 minutes
|
The Apgar scores of the infant at 1 and 5 minutes post delivery.
|
1 minute and 5 minutes
|
Umbilical artery pH
Time Frame: 24 hours
|
Umbilical artery pH
|
24 hours
|
Umbilical artery partial pressure of carbon dioxide
Time Frame: 24 hours
|
Umbilical artery partial pressure of carbon dioxide
|
24 hours
|
Umbilical artery partial pressure of oxygen
Time Frame: 24 hours
|
Umbilical artery partial pressure of oxygen
|
24 hours
|
Umbilical artery bicarbonate (mmol/L)
Time Frame: 24 hours
|
Umbilical artery bicarbonate
|
24 hours
|
Umbilical artery base excess (mmol/L)
Time Frame: 24 hours
|
Umbilical artery base excess
|
24 hours
|
Umbilical vein pH
Time Frame: 24 hours
|
Umbilical vein pH
|
24 hours
|
Umbilical vein partial pressure of carbon dioxide
Time Frame: 24 hours
|
Umbilical vein partial pressure of carbon dioxide
|
24 hours
|
Umbilical vein partial pressure of oxygen
Time Frame: 24 hours
|
Umbilical vein partial pressure of oxygen
|
24 hours
|
Umbilical vein bicarbonate (mmol/L)
Time Frame: 24 hours
|
Umbilical vein bicarbonate
|
24 hours
|
Umbilical vein base excess (mmol/L)
Time Frame: 24 hours
|
Umbilical vein base excess
|
24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- 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
- Norepinephrine
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- 16-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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Clinical Trials on Hypotension
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Clinical Trials on Norepinephrine
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General Hospital of Ningxia Medical UniversityCompleted
-
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-
Centre Hospitalier Universitaire de NiceNot yet recruitingIntensive Care Unit Syndrome | Cardiovascular Physiological PhenomenaFrance
-
Centre Hospitalier Universitaire, AmiensRecruitingShock | Surgery | Vasoplegia | NorepinephrineFrance
-
Cairo UniversityCompleted
-
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-
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-
The University of Texas at ArlingtonCompletedCardiovascular Diseases | Cardiovascular Risk Factor | VasoconstrictionUnited States
-
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Universitätsklinikum Hamburg-EppendorfCompletedBlood Pressure | Perioperative HypotensionGermany