HypotensionNCT02962986
A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries
A study testing Norepinephrine and Phenylephrine in people with Hypotension, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- What is being tested?
- Norepinephrine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient refusal
- Inability to communicate in English
- Allergy or hypersensitivity to phenylephrine
- Preexisting or pregnancy-induced hypertension
- Cardiovascular or cerebrovascular disease
- Fetal abnormalities
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Hypotension
- Being tested
- Norepinephrine, Phenylephrine
- Keywords
- vasopressor, blood pressure, cesarean section, spinal anesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Norepinephrine bitartrate
Norepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL
PhenylephrineDrug
Also called Phenylephrine Hydrochloride
Phenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine 6mcg | Active comparator | norepinephrine, given as 1mL IV boluses, to treat post-spinal hypotension Receives: Drug: Norepinephrine |
| phenylephrine 100mcg | Active comparator | phenylephrine, given as 1mL IV boluses, to treat post-spinal hypotension Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bradycardia: Heart rate less than 50 bpm
Heart rate less than 50 bpm, from induction of spinal anesthesia
Measured: 30 minutes
Secondary outcomes (20)
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.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
Tachycardia: Heart rate greater than 30% of baseline
Heart rate greater than 30%, from induction of spinal anesthesia to delivery of the fetus.
Measured: 30 minutes
Presence of nausea
Presence of nausea in patients from induction of spinal anesthesia to delivery of the fetus.
Measured: 30 minutes
Number of episodes of nausea
The number of episodes of nausea experienced by patients from induction of spinal anesthesia to delivery of the fetus.
Measured: 30 minutes
Presence of vomiting
Presence of vomiting in patients from induction of spinal anesthesia to delivery of the fetus.
Measured: 30 minutes
Number of episodes of vomiting
The number of episodes of vomiting experienced by patients from induction of spinal anesthesia to delivery of the fetus.
Measured: 30 minutes
Total dose of study drug given
Total dose of study drug given from induction of spinal anesthesia to delivery of the fetus.
Measured: 30 minutes
Apgar scores
The Apgar scores of the infant at 1 and 5 minutes post delivery.
Measured: 1 minute and 5 minutes
Umbilical artery pH
Umbilical artery pH
Measured: 24 hours
Umbilical artery partial pressure of carbon dioxide
Umbilical artery partial pressure of carbon dioxide
Measured: 24 hours
Umbilical artery partial pressure of oxygen
Umbilical artery partial pressure of oxygen
Measured: 24 hours
Umbilical artery bicarbonate (mmol/L)
Umbilical artery bicarbonate
Measured: 24 hours
Umbilical artery base excess (mmol/L)
Umbilical artery base excess
Measured: 24 hours
Umbilical vein pH
Umbilical vein pH
Measured: 24 hours
Umbilical vein partial pressure of carbon dioxide
Umbilical vein partial pressure of carbon dioxide
Measured: 24 hours
Umbilical vein partial pressure of oxygen
Umbilical vein partial pressure of oxygen
Measured: 24 hours
Umbilical vein bicarbonate (mmol/L)
Umbilical vein bicarbonate
Measured: 24 hours
Umbilical vein base excess (mmol/L)
Umbilical vein base excess
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962986
- Sponsor's protocol ID
- 16-07
- Status last verified
- May 2017
- First submitted
- 7 Nov 2016
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02962986
- Acronym / sponsor ID
- 16-07
- Conditions
- Hypotension
- Keywords
- vasopressor, blood pressure, cesarean section, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| norepinephrine 6mcg | Active comparator | Drug: Norepinephrinenorepinephrine, given as 1mL IV boluses, to treat post-spinal hypotension |
| phenylephrine 100mcg | Active comparator | Drug: Phenylephrinephenylephrine, given as 1mL IV boluses, to treat post-spinal hypotension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Patient refusal
- Inability to communicate in English
- Allergy or hypersensitivity to phenylephrine
- Preexisting or pregnancy-induced hypertension
- Cardiovascular or cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineAlso: Norepinephrine bitartrateNorepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL | Drug | norepinephrine 6mcg |
| PhenylephrineAlso: Phenylephrine HydrochloridePhenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL | Drug | phenylephrine 100mcg |
Primary outcome
Bradycardia: Heart rate less than 50 bpm
Time frame: 30 minutes
Heart rate less than 50 bpm, from induction of spinal anesthesia
20 secondary outcomes
Hypotension: Systolic blood pressure less than 80% of baseline
Time frame: 30 minutes
Number of hypotensive episodes
Time frame: 30 minutes
Hypertension: Systolic blood pressure at or above 120% of baseline
Time frame: 30 minutes
Tachycardia: Heart rate greater than 30% of baseline
Time frame: 30 minutes
Presence of nausea
Time frame: 30 minutes
Number of episodes of nausea
Time frame: 30 minutes
Presence of vomiting
Time frame: 30 minutes
Number of episodes of vomiting
Time frame: 30 minutes
Total dose of study drug given
Time frame: 30 minutes
Apgar scores
Time frame: 1 minute and 5 minutes
Umbilical artery pH
Time frame: 24 hours
Umbilical artery partial pressure of carbon dioxide
Time frame: 24 hours
Umbilical artery partial pressure of oxygen
Time frame: 24 hours
Umbilical artery bicarbonate (mmol/L)
Time frame: 24 hours
Umbilical artery base excess (mmol/L)
Time frame: 24 hours
Umbilical vein pH
Time frame: 24 hours
Umbilical vein partial pressure of carbon dioxide
Time frame: 24 hours
Umbilical vein partial pressure of oxygen
Time frame: 24 hours
Umbilical vein bicarbonate (mmol/L)
Time frame: 24 hours
Umbilical vein base excess (mmol/L)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Phenylephrine in people with Hypotension, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bradycardia: Heart rate less than 50 bpm (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.