HypotensionPhase 2NCT03702400
Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery
A Phase 2 study testing Phenylephrine 100 mcg and Norepinephrine 5 mcg in people with Hypotension and Spinal Anesthesia, run by Hospital dos Servidores do Estado do Rio de Janeiro at 1 site in Brazil.
Trial summary
This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. 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, Spinal Anesthesia
- What is being tested?
- Phenylephrine 100 mcg and Norepinephrine 5 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 1 Oct 2020
- Phase
- Phase 2
- 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
- Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia;
- Age above 18 years;
- Physical State American Society of Anesthesiologists (ASA) II and III;
- Weight between 50kg and 120kg;
- Height between 140cm and 180cm.
Who cannot join
- Refusal to participate in the study;
- Pregnant women with fetus with known abnormalities;
- Pregnant women with cardiovascular disease;
- Pregnant women with pregnancy-specific hypertensive disease;
- Allergy to any medication to be used in the study;
- Users of monoamine oxidase inhibitors;
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- Users of tricyclic antidepressants;
- Emergency caesarean section due to acute fetal distress;
- Situations in which the sensory level after single intrathecal injection of the local anesthetic does not reach at least T6 within 5 minutes after spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Federal Dos Servidores Do Estado
Rio de Janeiro, Rio de Janeiro, 22451-030
About this study
Official title: Randomized Double-blinded Comparison of Norepinephrine and Phenylephrine in Bolus for Maintenance of Blood Pressure During Spinal Anesthesia for Cesarean Delivery
This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.
Read the detailed description
This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram.
- Conditions
- Hypotension, Spinal Anesthesia
- Being tested
- Phenylephrine 100 mcg, Norepinephrine 5 mcg
- Keywords
- phenylephrine, norepinephrine, cesarean delivery under 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.
Phenylephrine 100 mcgDrug
Also called Fenilefrin
Phenylephrine at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug, 5 mL each bolus
Norepinephrine 5 mcgDrug
Also called Hemitartarato de norepinefrina
Norepinephrine at a dose of 5 mcg at dilution containing 1 mcg / mL, 5 mL each bolus
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine 100 mcg | Active comparator | Phenylephrine will be used at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug to be used whenever systolic blood pressure falls below 10% of baseline. Receives: Drug: Phenylephrine 100 mcg |
| Norepinephrine 5 mcg | Experimental | Norepinephrine will be used at a dose of 5 mcg at a dilution containing 1 mcg / mL to be used whenever systolic blood pressure falls below 10% of baseline. Receives: Drug: Norepinephrine 5 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bolus required
Number of bolus doses of phenylephrine and noradrenaline to maintain systemic arterial pressure at 90% of baseline in pregnant women undergoing spinal anesthesia for cesarean
Measured: during the procedure
Heart rate
Number of episodes of heart rate under 60 bpm while using phenylephrine and noradrenaline in pregnant women undergoing spinal anesthesia for cesarean
Measured: during the procedure
Secondary outcomes (3)
Neonatal gasometric outcome
To evaluate the neonatal outcome through the analysis of venous and arterial blood gases collected in the cord umbilical after birth.
Measured: during the procedure
Neonatal Apgar outcome
To evaluate the neonatal outcome through the classification given by the neonatologist responsible for the care to the newborn in the delivery room with the use of the Apgar Scale (0-10), 10 the better classification.
Measured: during the procedure
Nausea and vomiting
To evaluate the incidence of nausea and vomiting of the parturient during cesarean section
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Jun 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a randomized, double-blinded study, 76 healthy patients having cesarean delivery under spinal anesthesia will be randomized, using an electronic system (the Randomizer App®, Version 3.2 Wisse Keizer program), to have systolic blood pressure maintained with bolus of phenylephrine at a dose of 100 mcg bolus (at a dilution containing 20 mcg / mL), or with norepinephrine at a dose of 5 mcg (at a dilution containing 1 mcg / mL).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital dos Servidores do Estado do Rio de Janeiro
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DANIEL VIEIRA DE QUEIROZ, Hospital dos Servidores do Estado do Rio de Janeiro
- Investigators
- DANIEL V DE QUEIROZ, Principal investigator, HOSPITAL FEDERAL DOS SERVIDORES DO ESTADO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702400
- Sponsor's protocol ID
- 000.603
- Status last verified
- Apr 2021
- First submitted
- 6 Oct 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.
PubMed 25635593Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.
PubMed 27720613
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blinded Comparison of Norepinephrine and Phenylephrine in Bolus for Maintenance of Blood Pressure During Spinal Anesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03702400
- Acronym / sponsor ID
- 000.603
- Conditions
- Hypotension, Spinal Anesthesia
- Keywords
- phenylephrine, norepinephrine, cesarean delivery under spinal anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospital dos Servidores do Estado do Rio de JaneiroOther government
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 11 Oct 2018 (actual)
- 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.
This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline.
Detailed description
This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In a randomized, double-blinded study, 76 healthy patients having cesarean delivery under spinal anesthesia will be randomized, using an electronic system (the Randomizer App®, Version 3.2 Wisse Keizer program), to have systolic blood pressure maintained with bolus of phenylephrine at a dose of 100 mcg bolus (at a dilution containing 20 mcg / mL), or with norepinephrine at a dose of 5 mcg (at a dilution containing 1 mcg / mL).
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine 100 mcg | Active comparator | Drug: Phenylephrine 100 mcgPhenylephrine will be used at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug to be used whenever systolic blood pressure falls below 10% of baseline. |
| Norepinephrine 5 mcg | Experimental | Drug: Norepinephrine 5 mcgNorepinephrine will be used at a dose of 5 mcg at a dilution containing 1 mcg / mL to be used whenever systolic blood pressure falls below 10% of baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia;
- Age above 18 years;
- Physical State American Society of Anesthesiologists (ASA) II and III;
- Weight between 50kg and 120kg;
- Height between 140cm and 180cm.
Key exclusion criteria (9 listed)
- Refusal to participate in the study;
- Pregnant women with fetus with known abnormalities;
- Pregnant women with cardiovascular disease;
- Pregnant women with pregnancy-specific hypertensive disease;
- Allergy to any medication to be used in the study;
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 |
|---|---|---|
| Phenylephrine 100 mcgAlso: FenilefrinPhenylephrine at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug, 5 mL each bolus | Drug | Phenylephrine 100 mcg |
| Norepinephrine 5 mcgAlso: Hemitartarato de norepinefrinaNorepinephrine at a dose of 5 mcg at dilution containing 1 mcg / mL, 5 mL each bolus | Drug | Norepinephrine 5 mcg |
Primary outcome
Number of bolus required
Time frame: during the procedure
Number of bolus doses of phenylephrine and noradrenaline to maintain systemic arterial pressure at 90% of baseline in pregnant women undergoing spinal anesthesia for cesarean
Heart rate
Time frame: during the procedure
Number of episodes of heart rate under 60 bpm while using phenylephrine and noradrenaline in pregnant women undergoing spinal anesthesia for cesarean
3 secondary outcomes
Neonatal gasometric outcome
Time frame: during the procedure
Neonatal Apgar outcome
Time frame: during the procedure
Nausea and vomiting
Time frame: during the procedure
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 13 Apr 2021.
- Background: PubMed 25635593Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015 Apr;122(4):736-45. doi: 10.1097/ALN.0000000000000601.
- Background: PubMed 27720613Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.
- 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.
DANIEL V DE QUEIROZ principal investigator
HOSPITAL FEDERAL DOS SERVIDORES DO ESTADO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Phenylephrine 100 mcg and Norepinephrine 5 mcg in people with Hypotension and Spinal Anesthesia, run by Hospital dos Servidores do Estado do Rio de Janeiro at 1 site in Brazil.
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 5 inclusion and 9 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 13 Apr 2021. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of bolus required (time frame: during the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702400, which also lists 2 linked publications.
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 13 Apr 2021.