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A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Norepinephrine
Phenylephrine
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring vasopressor, blood pressure, cesarean section, spinal anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

norepinephrine 6mcg

phenylephrine 100mcg

Arm Description

norepinephrine, given as 1mL IV boluses, to treat post-spinal hypotension

phenylephrine, given as 1mL IV boluses, to treat post-spinal hypotension

Outcomes

Primary Outcome Measures

Bradycardia: Heart rate less than 50 bpm
Heart rate less than 50 bpm, from induction of spinal anesthesia

Secondary Outcome Measures

Hypotension: Systolic blood pressure less than 80% of baseline
Systolic blood pressure below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.
Number of hypotensive episodes
The number of times the systolic blood pressure measures below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.
Hypertension: Systolic blood pressure at or above 120% of baseline
Systolic blood pressure at or above 120% of baseline, from induction of spinal anesthesia to delivery of the fetus.
Tachycardia: Heart rate greater than 30% of baseline
Heart rate greater than 30%, from induction of spinal anesthesia to delivery of the fetus.
Presence of nausea
Presence of nausea in patients from induction of spinal anesthesia to delivery of the fetus.
Number of episodes of nausea
The number of episodes of nausea experienced by patients from induction of spinal anesthesia to delivery of the fetus.
Presence of vomiting
Presence of vomiting in patients from induction of spinal anesthesia to delivery of the fetus.
Number of episodes of vomiting
The number of episodes of vomiting experienced by patients from induction of spinal anesthesia to delivery of the fetus.
Total dose of study drug given
Total dose of study drug given from induction of spinal anesthesia to delivery of the fetus.
Apgar scores
The Apgar scores of the infant at 1 and 5 minutes post delivery.
Umbilical artery pH
Umbilical artery pH
Umbilical artery partial pressure of carbon dioxide
Umbilical artery partial pressure of carbon dioxide
Umbilical artery partial pressure of oxygen
Umbilical artery partial pressure of oxygen
Umbilical artery bicarbonate (mmol/L)
Umbilical artery bicarbonate
Umbilical artery base excess (mmol/L)
Umbilical artery base excess
Umbilical vein pH
Umbilical vein pH
Umbilical vein partial pressure of carbon dioxide
Umbilical vein partial pressure of carbon dioxide
Umbilical vein partial pressure of oxygen
Umbilical vein partial pressure of oxygen
Umbilical vein bicarbonate (mmol/L)
Umbilical vein bicarbonate
Umbilical vein base excess (mmol/L)
Umbilical vein base excess

Full Information

First Posted
November 7, 2016
Last Updated
May 23, 2017
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02962986
Brief Title
A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries
Official Title
A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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. These studies have been limited to using norepinephrine as an infusion and there is limited data with it being used as a bolus to prevent hypotension. A recent study was undertaken at Mount Sinai hospital to determine the ED90 of norepinephrine to treat post spinal hypotension. Secondary outcome data from this trial showed that the incidence of bradycardia associated with this treatment is approximately 7.5%, several times less when compared to the reported 30% with phenylephrine. It would therefore be prudent at this stage to undertake a randomized trial comparing the hemodynamic profile of phenylephrine (our standard practice) and norepinephrine used as intermittent boluses to prevent hypotension and avoid decrease in heart rate during cesarean delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
vasopressor, blood pressure, cesarean section, spinal anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
norepinephrine 6mcg
Arm Type
Active Comparator
Arm Description
norepinephrine, given as 1mL IV boluses, to treat post-spinal hypotension
Arm Title
phenylephrine 100mcg
Arm Type
Active Comparator
Arm Description
phenylephrine, given as 1mL IV boluses, to treat post-spinal hypotension
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Norepinephrine bitartrate
Intervention Description
Norepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Phenylephrine Hydrochloride
Intervention Description
Phenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL
Primary Outcome Measure Information:
Title
Bradycardia: Heart rate less than 50 bpm
Description
Heart rate less than 50 bpm, from induction of spinal anesthesia
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Hypotension: Systolic blood pressure less than 80% of baseline
Description
Systolic blood pressure below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Number of hypotensive episodes
Description
The number of times the systolic blood pressure measures below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Hypertension: Systolic blood pressure at or above 120% of baseline
Description
Systolic blood pressure at or above 120% of baseline, from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Tachycardia: Heart rate greater than 30% of baseline
Description
Heart rate greater than 30%, from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Presence of nausea
Description
Presence of nausea in patients from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Number of episodes of nausea
Description
The number of episodes of nausea experienced by patients from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Presence of vomiting
Description
Presence of vomiting in patients from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Number of episodes of vomiting
Description
The number of episodes of vomiting experienced by patients from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Total dose of study drug given
Description
Total dose of study drug given from induction of spinal anesthesia to delivery of the fetus.
Time Frame
30 minutes
Title
Apgar scores
Description
The Apgar scores of the infant at 1 and 5 minutes post delivery.
Time Frame
1 minute and 5 minutes
Title
Umbilical artery pH
Description
Umbilical artery pH
Time Frame
24 hours
Title
Umbilical artery partial pressure of carbon dioxide
Description
Umbilical artery partial pressure of carbon dioxide
Time Frame
24 hours
Title
Umbilical artery partial pressure of oxygen
Description
Umbilical artery partial pressure of oxygen
Time Frame
24 hours
Title
Umbilical artery bicarbonate (mmol/L)
Description
Umbilical artery bicarbonate
Time Frame
24 hours
Title
Umbilical artery base excess (mmol/L)
Description
Umbilical artery base excess
Time Frame
24 hours
Title
Umbilical vein pH
Description
Umbilical vein pH
Time Frame
24 hours
Title
Umbilical vein partial pressure of carbon dioxide
Description
Umbilical vein partial pressure of carbon dioxide
Time Frame
24 hours
Title
Umbilical vein partial pressure of oxygen
Description
Umbilical vein partial pressure of oxygen
Time Frame
24 hours
Title
Umbilical vein bicarbonate (mmol/L)
Description
Umbilical vein bicarbonate
Time Frame
24 hours
Title
Umbilical vein base excess (mmol/L)
Description
Umbilical vein base excess
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries

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