HypotensionPhase 4NCT02802683
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
A Phase 4 study testing Bupivacaine, Levobupivacaine and Phenylephrine in people with Hypotension, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics. 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?
- Bupivacaine, Levobupivacaine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Jun 2016
- 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
- pregnant woman scheduled for elective cesarean delivery under spinal anesthesia
Who cannot join
- patients who refuse involved
- patients who have pre-eclampsia
- patients who have heart disease
- patients who fetal distress is suspicious
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.
- Conditions
- Hypotension
- Being tested
- Bupivacaine, Levobupivacaine, Phenylephrine, normal saline
- Keywords
- Hypotension, cesarean section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Heavy bupivacaine
spinal anesthesia with hyperbaric bupivacaine
LevobupivacaineDrug
Also called chirocaine
spinal anesthesia with isobaric levobupivacaine
PhenylephrineDrug
continous infusion of phenylephrine
normal salineDrug
continous infusion of normal saline
| Study group | Role | What they receive |
|---|---|---|
| "BUPI","P" | Experimental | patients who received hyperbaric bupivacaine and continous infusion of phenylephrine Receives: Drug: Bupivacaine; Drug: Phenylephrine |
| "BUPI","N" | Placebo comparator | patients who received hyperbaric bupivacaine and continous infusion of normal saline Receives: Drug: Bupivacaine; Drug: normal saline |
| "LEVO","P" | Experimental | patients who received isobaric levobupivacaine and continous infusion of phenylephrine Receives: Drug: Levobupivacaine; Drug: Phenylephrine |
| "LEVO","N" | Active comparator | patients who received isobaric levobupivacaine and continous infusion of normal saline Receives: Drug: Levobupivacaine; Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypotension events with treatment related
blood pressure was obtained every 1min. A 20% decrease or more decrease in SAP compared to baseline was considered as hypotension. Hypotensive events during first 30 min was recorded as primary outcome.
Measured: during 30min after spinal anesthesia
Secondary outcomes (1)
total dose of phenylephrine
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionJun 2016
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
- Investigators
- Bahk, Principal investigator, Seoul National University Hospital Seoul, Korea, Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802683
- Sponsor's protocol ID
- JHBahk_C/S
- Status last verified
- Jul 2016
- First submitted
- 4 May 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02802683
- Acronym / sponsor ID
- JHBahk_C/S
- Conditions
- Hypotension
- Keywords
- Hypotension, cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Jun 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 the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| "BUPI","P" | Experimental | Drug: Bupivacaine, Drug: Phenylephrinepatients who received hyperbaric bupivacaine and continous infusion of phenylephrine |
| "BUPI","N" | Placebo comparator | Drug: Bupivacaine, Drug: normal salinepatients who received hyperbaric bupivacaine and continous infusion of normal saline |
| "LEVO","P" | Experimental | Drug: Levobupivacaine, Drug: Phenylephrinepatients who received isobaric levobupivacaine and continous infusion of phenylephrine |
| "LEVO","N" | Active comparator | Drug: Levobupivacaine, Drug: normal salinepatients who received isobaric levobupivacaine and continous infusion of normal saline |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant woman scheduled for elective cesarean delivery under spinal anesthesia
Key exclusion criteria (4 listed)
- patients who refuse involved
- patients who have pre-eclampsia
- patients who have heart disease
- patients who fetal distress is suspicious
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 |
|---|---|---|
| BupivacaineAlso: Heavy bupivacainespinal anesthesia with hyperbaric bupivacaine | Drug | "BUPI","N", "BUPI","P" |
| LevobupivacaineAlso: chirocainespinal anesthesia with isobaric levobupivacaine | Drug | "LEVO","N", "LEVO","P" |
| Phenylephrinecontinous infusion of phenylephrine | Drug | "BUPI","P", "LEVO","P" |
| normal salinecontinous infusion of normal saline | Drug | "BUPI","N", "LEVO","N" |
Primary outcome
Number of hypotension events with treatment related
Time frame: during 30min after spinal anesthesia
blood pressure was obtained every 1min. A 20% decrease or more decrease in SAP compared to baseline was considered as hypotension. Hypotensive events during first 30 min was recorded as primary outcome.
1 secondary outcome
total dose of phenylephrine
Time frame: during the surgery
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 6 Jul 2016.
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Applying HPI in Oral Cancer Surgery
the Severity and Duration of Intraoperative Hypotension
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Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
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RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
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.
Bahk principal investigator
Seoul National University Hospital Seoul, Korea, Republic of
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 Bupivacaine, Levobupivacaine and Phenylephrine in people with Hypotension, run by Seoul 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 4 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 6 Jul 2016. 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. Some participants in this study may receive a placebo. 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?
Number of hypotension events with treatment related (time frame: during 30min after spinal anesthesia). 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 6 Jul 2016.