Cesarean SectionPhase 4NCT00996190
Best Regimen for Phenylephrine Administration During Cesarean Section
A Phase 4 study testing Phenylephrine in people with Cesarean Section and Cardiac Output, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Cardiac Output, Hypotension
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Aug 2010
- Phase
- Phase 4
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to communicate in English
- Elective Cesarean Delivery 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
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
- History of diabetes, excluding gestational diabetes
- Contra-indications for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Determine the Best Regimen for Administration of Phenylephrine During Spinal Anesthesia for Cesarean Delivery, as Determined by Maternal Blood Pressure and Cardiac Output
During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. This low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.
Currently there are 2 methods of phenylephrine administration during Cesarean section. One method is by intermittent bolus and the other is by continuous infusion. It is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output.
Read more
In this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.
The hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.
- Conditions
- Cesarean Section, Cardiac Output, Hypotension
- Being tested
- Phenylephrine
- Keywords
- transthoracic bioreactance, noninvasive monitoring, vasopressor, blood pressure
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine Intermittent Bolus | Active comparator | Bolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution). Receives: Drug: Phenylephrine |
| Phenylephrine Continuous Infusion | Active comparator | Infusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution). Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum decrease in cardiac output in the pre-delivery period.
Measured: 30 minutes
Secondary outcomes (6)
Maximum decrease in heart rate in the pre-delivery period.
Measured: 30 minutes
Incidence of hypotension in the pre-delivery period (BP < 80% baseline)
Measured: 30 minutes
Incidence of hypertension in the pre-delivery period (BP > 120% baseline)
Measured: 30 minutes
Incidence of nausea and vomiting in the pre-delivery period
Measured: 30 minutes
Total dose of phenylephrine in the pre-delivery period
Measured: 30 minutes
Umbilical artery and vein blood gases
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 posted16 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996190
- Sponsor's protocol ID
- 09-03
- Status last verified
- Feb 2011
- First submitted
- 15 Oct 2009
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Best Regimen for Administration of Phenylephrine During Spinal Anesthesia for Cesarean Delivery, as Determined by Maternal Blood Pressure and Cardiac Output
- ClinicalTrials.gov ID
- NCT00996190
- Acronym / sponsor ID
- 09-03
- Conditions
- Cesarean Section, Cardiac Output, Hypotension
- Keywords
- transthoracic bioreactance, noninvasive monitoring, vasopressor, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Oct 2009 (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.
During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. This low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.
Currently there are 2 methods of phenylephrine administration during Cesarean section. One method is by intermittent bolus and the other is by continuous infusion. It is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output.
In this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.
The hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.
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 |
|---|---|---|
| Phenylephrine Intermittent Bolus | Active comparator | Drug: PhenylephrineBolus syringe will contain 120 micrograms/mL of phenylephrine. Infusion solution bag will contain placebo (saline solution). |
| Phenylephrine Continuous Infusion | Active comparator | Drug: PhenylephrineInfusion solution bag will contain 120 micrograms/mL of phenylephrine. Bolus syringe will contain placebo (saline solution). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to communicate in English
- Elective Cesarean Delivery under spinal anesthesia
- Normal singleton pregnancy beyond 36 weeks gestation
- ASA physical status I/II
- Weight 50-100 kg, height 150-180 cm
Key exclusion criteria (8 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 |
|---|---|---|
| Phenylephrinephenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose | Drug | Phenylephrine Continuous Infusion, Phenylephrine Intermittent Bolus |
Primary outcome
The maximum decrease in cardiac output in the pre-delivery period.
Time frame: 30 minutes
6 secondary outcomes
Maximum decrease in heart rate in the pre-delivery period.
Time frame: 30 minutes
Incidence of hypotension in the pre-delivery period (BP < 80% baseline)
Time frame: 30 minutes
Incidence of hypertension in the pre-delivery period (BP > 120% baseline)
Time frame: 30 minutes
Incidence of nausea and vomiting in the pre-delivery period
Time frame: 30 minutes
Total dose of phenylephrine in the pre-delivery period
Time frame: 30 minutes
Umbilical artery and vein blood gases
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 23 Feb 2011.
Related trials for Cesarean Section
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
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Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
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Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
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 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 Phase 4 study testing Phenylephrine in people with Cesarean Section and Cardiac Output, 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 8 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 23 Feb 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The maximum decrease in cardiac output in the pre-delivery period. (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 23 Feb 2011.