HypotensionPhase 2NCT01108874
Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Cesarean Section
A Phase 2 study testing Metaraminol in people with Hypotension, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections. 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?
- Metaraminol
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Aug 2010
- 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
- Elective CS under spinal anesthesia
- Normal singleton pregnancy beyond 36 weeks gestation
- ASA physical status I/II
- Age over 18 years
Who cannot join
- Patient refusal
- Allergy to metaraminol
- Preexisting or pregnancy-induced hypertension
- Cardiovascular or cerebrovascular disease
- Fetal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Elective Cesarean Section
The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.
Read the detailed description
The purpose of this study is to determine the effective dose 90% (ED90) of metaraminol to treat hypotension after spinal anesthesia in elective cesarean sections (CS). It is a double-blind study that uses the biased-coin up-down sequential allocation method to determine the ED90 of metaraminol.
Baseline systolic blood pressure (SBP) will be determined by three automated measures 3 minutes apart just before CS. During the period from induction of spinal anesthesia to fetal delivery SBP will be monitored every minute and metaraminol will be administered every time it is lower than baseline value. If SBP falls below 80% of baseline value, the treatment will be considered a failure. An adequate response will be defined as the absence of hypotension during the study period.
- Conditions
- Hypotension
- Being tested
- Metaraminol
- Keywords
- Cesarean section, Hypotension, Metaraminol, Vasoconstrictor Agents, Adult, Female, Pregnancy, Anesthesia, Obstetrical/adverse effects, Anesthesia,Spinal, Blood Pressure/drug effects, Nausea, Vomiting
- Medical subject headings
- Hypotension, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaraminolDrug
Patients will be given metaraminol every time SBP falls below baseline value.
What is being measured
The primary outcome is the main question the study is designed to answer.
The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.
Bolus doses of metaraminol will be used every time SBP falls below baseline values and maternal responses to doses will be used to build a dose response curve from where ED90 will be estimated.
Measured: From spinal induction until delivery (on average 30-60min)
Secondary outcomes (8)
Maternal Demographics (Age, Height, Weight and Gestational Age)
Incidence of Nausea and Vomiting
Measured: From spinal induction until delivery (on average 30-60min)
Time between skin incision and delivery
Time between uterine incision and delivery
Total dose of metaraminol
Number of Participants with Hypertension or Bradycardia as a Measure of Safety and Tolerability
Measured: From spinal induction until delivery (on average 30-60min)
Umbilical blood gases
Fetal well-being with Apgar scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (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.
- Publications (4)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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Jefferson Clivatti, MD, Principal investigator, Disciplina de Anestesiologia, UNIFESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108874
- Sponsor's protocol ID
- CEP1241/09
- Status last verified
- Sep 2010
- First submitted
- 19 Apr 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
Publications
Tanaka M, Balki M, Parkes RK, Carvalho JC. ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. Int J Obstet Anesth. 2009 Apr;18(2):125-30. doi: 10.1016/j.ijoa.2008.09.008. Epub 2009 Jan 21.
PubMed 19162468Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.
PubMed 17585226Ngan Kee WD, Lau TK, Khaw KS, Lee BB. Comparison of metaraminol and ephedrine infusions for maintaining arterial pressure during spinal anesthesia for elective cesarean section. Anesthesiology. 2001 Aug;95(2):307-13. doi: 10.1097/00000542-200108000-00009.
PubMed 11506099Ngan Kee WD, Lee A. Multivariate analysis of factors associated with umbilical arterial pH and standard base excess after Caesarean section under spinal anaesthesia. Anaesthesia. 2003 Feb;58(2):125-30. doi: 10.1046/j.1365-2044.2003.02888.x.
PubMed 12562407
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT01108874
- Acronym / sponsor ID
- CEP1241/09
- Conditions
- Hypotension
- Keywords
- Cesarean section, Hypotension, Metaraminol, Vasoconstrictor Agents, Adult, Female, Pregnancy, Anesthesia, Obstetrical/adverse effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Apr 2010 (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 find the best dose of metaraminol to be used in patients during elective cesarean sections.
Detailed description
The purpose of this study is to determine the effective dose 90% (ED90) of metaraminol to treat hypotension after spinal anesthesia in elective cesarean sections (CS). It is a double-blind study that uses the biased-coin up-down sequential allocation method to determine the ED90 of metaraminol.
Baseline systolic blood pressure (SBP) will be determined by three automated measures 3 minutes apart just before CS. During the period from induction of spinal anesthesia to fetal delivery SBP will be monitored every minute and metaraminol will be administered every time it is lower than baseline value. If SBP falls below 80% of baseline value, the treatment will be considered a failure. An adequate response will be defined as the absence of hypotension during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective CS under spinal anesthesia
- Normal singleton pregnancy beyond 36 weeks gestation
- ASA physical status I/II
- Age over 18 years
Key exclusion criteria (5 listed)
- Patient refusal
- Allergy to metaraminol
- Preexisting or pregnancy-induced hypertension
- Cardiovascular or cerebrovascular disease
- Fetal abnormalities
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 |
|---|---|---|
| MetaraminolPatients will be given metaraminol every time SBP falls below baseline value. | Drug | – |
Primary outcome
The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.
Time frame: From spinal induction until delivery (on average 30-60min)
Bolus doses of metaraminol will be used every time SBP falls below baseline values and maternal responses to doses will be used to build a dose response curve from where ED90 will be estimated.
8 secondary outcomes
Maternal Demographics (Age, Height, Weight and Gestational Age)
Incidence of Nausea and Vomiting
Time frame: From spinal induction until delivery (on average 30-60min)
Time between skin incision and delivery
Time between uterine incision and delivery
Total dose of metaraminol
Number of Participants with Hypertension or Bradycardia as a Measure of Safety and Tolerability
Time frame: From spinal induction until delivery (on average 30-60min)
Umbilical blood gases
Fetal well-being with Apgar scores
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 1 Oct 2010.
- Background: PubMed 19162468Tanaka M, Balki M, Parkes RK, Carvalho JC. ED95 of phenylephrine to prevent spinal-induced hypotension and/or nausea at elective cesarean delivery. Int J Obstet Anesth. 2009 Apr;18(2):125-30. doi: 10.1016/j.ijoa.2008.09.008. Epub 2009 Jan 21.
- Background: PubMed 17585226Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.
- Background: PubMed 11506099Ngan Kee WD, Lau TK, Khaw KS, Lee BB. Comparison of metaraminol and ephedrine infusions for maintaining arterial pressure during spinal anesthesia for elective cesarean section. Anesthesiology. 2001 Aug;95(2):307-13. doi: 10.1097/00000542-200108000-00009.
- Background: PubMed 12562407Ngan Kee WD, Lee A. Multivariate analysis of factors associated with umbilical arterial pH and standard base excess after Caesarean section under spinal anaesthesia. Anaesthesia. 2003 Feb;58(2):125-30. doi: 10.1046/j.1365-2044.2003.02888.x.
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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.
Jefferson Clivatti, MD principal investigator
Disciplina de Anestesiologia, UNIFESP
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 Metaraminol in people with Hypotension, run by Federal University of São Paulo 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 4 inclusion and 5 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 1 Oct 2010. 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?
The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined. (time frame: From spinal induction until delivery (on average 30-60min)). 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 NCT01108874, which also lists 4 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 1 Oct 2010.