HypotensionPhase 4NCT02969239
Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery
A Phase 4 study testing Norepinephrine and Phenylephrine in people with Hypotension, run by Jeju National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare norepinephrine and phenylephrine on the effects of maintaining the cardiac output in Cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- 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
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Jul 2017
- 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA class I and II, term pregnancy (gestational age>37weeks), planned spinal anesthesia for elective cesarean section
Who cannot join
- preexisting or gestational hypertension, cerebrovascular or cardiovascular disease, any contraindication to the spinal anesthesia, fetal anormaly, weight<50kg or >100kg, and height<140cm or >180cm.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jeju National University Hospital
Jeju City, Jeju-do, 690-767
AE RYOUNG LEE, +82647171810, nanrong95@naver.com
About this study
Official title: Norepinephrine and Phenylephrine for Cesarean Section
The purpose of this study is to compare norepinephrine and phenylephrine on the effects of maintaining the cardiac output in Cesarean section under spinal anesthesia.
Read the detailed description
CO was measured using the NICOM® monitor. Bioreactance, a development from impedance technology, is also emerging as an accessible mode of continuous CO monitoring in the operating room and can provide valuable insight into the hemodynamic effects of our interventions. This method of monitoring provides continuous CO, stroke volume (SV) and heart rate (HR) monitoring, and intermittent BP and SVR assessments at 1-minute intervals.
Either phenylephrine (100 mcg/ml) or norepinephrine (0.5 mcg/ml) in 50-ml syringe that were labeled "study drug". She was not involved in patient's care or study assessment.
The hypotension was defined as systolic blood pressure <80% of baseline or < 90 mmHg, and managed with study drug (1 ml) intravenously. The bradycardia was defined as HR < 60 beats/min and was recorded and managed with atropine (0.5 mg) intravenously as HR < 45 beats/min. The presence of nausea and vomiting was measured on a 3 point scale (1 = no nausea and vomiting, 2 = nausea only, and 3 = both nausea and vomiting) and managed with ondansetron (4mg) intravenously.
- Conditions
- Hypotension
- Being tested
- Norepinephrine, Phenylephrine
- 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 vasopressor given
bolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
PhenylephrineDrug
Also called vasopressor given
bolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine | Experimental | norepinephrine 5mcg intravenously administered Receives: Drug: Norepinephrine |
| phenylephrine | Active comparator | phenylephrine 100mcg intravenously administered Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cardiac index (L/min/m2)
Change from Baseline at time 2, 3, 4, and 5
Measured: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
Secondary outcomes (4)
change of Stroke volume (ml/beat)
Change from Baseline at time 2, 3, 4, and 5
Measured: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
change of Total Peripheral Resistance (dynes sec/cm3)
Change from Baseline at time 2, 3, 4, and 5
Measured: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
change of Systolic blood pressure (mmHg)
Change from Baseline at time 2, 3, 4, and 5
Measured: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery
change of heart rate (beats per minute)
Change from Baseline at time 2, 3, 4, and 5
Measured: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeju National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ae ryoung Lee, Jeju National University Hospital
- Investigators
- AE RYOUNG LEE, Study director, Jeju National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969239
- Sponsor's protocol ID
- ALee-OB-2016-1
- Status last verified
- Mar 2017
- First submitted
- 13 Oct 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine and Phenylephrine for Cesarean Section
- ClinicalTrials.gov ID
- NCT02969239
- Acronym / sponsor ID
- ALee-OB-2016-1
- Conditions
- Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jeju National University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 21 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.
The purpose of this study is to compare norepinephrine and phenylephrine on the effects of maintaining the cardiac output in Cesarean section under spinal anesthesia.
Detailed description
CO was measured using the NICOM® monitor. Bioreactance, a development from impedance technology, is also emerging as an accessible mode of continuous CO monitoring in the operating room and can provide valuable insight into the hemodynamic effects of our interventions. This method of monitoring provides continuous CO, stroke volume (SV) and heart rate (HR) monitoring, and intermittent BP and SVR assessments at 1-minute intervals.
Either phenylephrine (100 mcg/ml) or norepinephrine (0.5 mcg/ml) in 50-ml syringe that were labeled "study drug". She was not involved in patient's care or study assessment.
The hypotension was defined as systolic blood pressure <80% of baseline or < 90 mmHg, and managed with study drug (1 ml) intravenously. The bradycardia was defined as HR < 60 beats/min and was recorded and managed with atropine (0.5 mg) intravenously as HR < 45 beats/min. The presence of nausea and vomiting was measured on a 3 point scale (1 = no nausea and vomiting, 2 = nausea only, and 3 = both nausea and vomiting) and managed with ondansetron (4mg) intravenously.
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 | Experimental | Drug: Norepinephrinenorepinephrine 5mcg intravenously administered |
| phenylephrine | Active comparator | Drug: Phenylephrinephenylephrine 100mcg intravenously administered |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA class I and II, term pregnancy (gestational age>37weeks), planned spinal anesthesia for elective cesarean section
Key exclusion criteria (1 listed)
- preexisting or gestational hypertension, cerebrovascular or cardiovascular disease, any contraindication to the spinal anesthesia, fetal anormaly, weight<50kg or >100kg, and height<140cm or >180cm.
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: vasopressor givenbolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline | Drug | norepinephrine |
| PhenylephrineAlso: vasopressor givenbolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline | Drug | phenylephrine |
Primary outcome
change of cardiac index (L/min/m2)
Time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
Change from Baseline at time 2, 3, 4, and 5
4 secondary outcomes
change of Stroke volume (ml/beat)
Time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
change of Total Peripheral Resistance (dynes sec/cm3)
Time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
change of Systolic blood pressure (mmHg)
Time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery
change of heart rate (beats per minute)
Time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
AE RYOUNG LEE study director
Jeju National University 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 Norepinephrine and Phenylephrine in people with Hypotension, run by Jeju National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Mar 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AE RYOUNG LEE (+82647171810, nanrong95@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of cardiac index (L/min/m2) (time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery). 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 10 Mar 2017.