NCT02962986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

November 7, 2016

Last Update Submit

May 23, 2017

Conditions

Hypotension

Keywords

vasopressorblood pressurecesarean sectionspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Bradycardia: Heart rate less than 50 bpm

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

    30 minutes

Secondary Outcomes (20)

  • Hypotension: Systolic blood pressure less than 80% of baseline

    30 minutes

  • Number of hypotensive episodes

    30 minutes

  • Hypertension: Systolic blood pressure at or above 120% of baseline

    30 minutes

  • Tachycardia: Heart rate greater than 30% of baseline

    30 minutes

  • Presence of nausea

    30 minutes

  • +15 more secondary outcomes

Study Arms (2)

norepinephrine 6mcg

ACTIVE COMPARATOR

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

Drug: Norepinephrine

phenylephrine 100mcg

ACTIVE COMPARATOR

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

Drug: Phenylephrine

Interventions

NorepinephrineDRUG

Norepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL

Also known as: Norepinephrine bitartrate
norepinephrine 6mcg
PhenylephrineDRUG

Phenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL

Also known as: Phenylephrine Hydrochloride
phenylephrine 100mcg

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • Allergy or hypersensitivity to sulfite
  • Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
  • Untreated hyperthyroid patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Hypotension

Interventions

NorepinephrinePhenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Jose CA Carvalho, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 15, 2016

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)