Cardiac OutputPhase 4NCT02737813
Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section
A Phase 4 study testing Isobaric marcaine and Hyperbaric marcaine in people with Cardiac Output and Hypotension, run by Mahidol University at 1 site in Thailand.
Trial summary
Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiac Output, Hypotension, Anesthesia, Spinal
- What is being tested?
- Isobaric marcaine and Hyperbaric marcaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteThailand
- Study dates
- 29 Mar 2016to 15 Nov 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology classification I - II
- Elective or urgency Cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane
- Singleton pregnancy
- Body mass index < 40 kg/m2
Who cannot join
- Pregnancy <35 weeks gestational age
- Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia
- History of allergy to the study drugs
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials
Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine
- Conditions
- Cardiac Output, Hypotension, Anesthesia, Spinal
- Being tested
- Isobaric marcaine, Hyperbaric marcaine
- Keywords
- isobaric marcaine, hyperbaric marcaine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isobaric marcaineDrug
Also called bupivacaine
Isobaric marcaine 2.2 mL for spinal block
Hyperbaric marcaineDrug
Also called bupivacaine
Hyperbaric marcaine 2.2 mL for spinal block
| Study group | Role | What they receive |
|---|---|---|
| Isobaric Marcaine | Experimental | Isobaric Marcaine 2.2 mL for spinal block Receives: Drug: Isobaric marcaine |
| Hyperbaric Marcaine | Active comparator | Hyperbaric Marcaine 2.2 mL for spinal block Receives: Drug: Hyperbaric marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cardiac output (L/min) after spinal block
The investigators will measure cardiac output using non-invasive methods (USCOM) before spinal block and 5 minutes after spinal block.
Measured: 5 minutes after spinal block
Secondary outcomes (2)
Total dose of vasopressor
The investigators will record the total dose that treat hypotension during preoperative period
Measured: 2 hours
Number of patients who experience systolic blood pressure < 25% of preoperative measurement
The investigators will monitor blood pressure at interval; before spinal block, then after spinal block every 1 minute for 10 for 10 times, every 2 minute for 5 times, every 3 minutes until delivery then every 5 minutes til the end of surgery. If the patient's systolic blood pressure is declined, vasopressor will be given.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start29 Mar 2016
- Primary completion11 Nov 2016
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737813
- Sponsor's protocol ID
- Marcaine
- Status last verified
- Jul 2017
- First submitted
- 23 Mar 2016
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials
- ClinicalTrials.gov ID
- NCT02737813
- Acronym / sponsor ID
- Marcaine
- Conditions
- Cardiac Output, Hypotension, Anesthesia, Spinal
- Keywords
- isobaric marcaine, hyperbaric marcaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 14 Apr 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.
Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine
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 |
|---|---|---|
| Isobaric Marcaine | Experimental | Drug: Isobaric marcaineIsobaric Marcaine 2.2 mL for spinal block |
| Hyperbaric Marcaine | Active comparator | Drug: Hyperbaric marcaineHyperbaric Marcaine 2.2 mL for spinal block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology classification I - II
- Elective or urgency Cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane
- Singleton pregnancy
- Body mass index < 40 kg/m2
Key exclusion criteria (3 listed)
- Pregnancy <35 weeks gestational age
- Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia
- History of allergy to the study drugs
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 |
|---|---|---|
| Isobaric marcaineAlso: bupivacaineIsobaric marcaine 2.2 mL for spinal block | Drug | Isobaric Marcaine |
| Hyperbaric marcaineAlso: bupivacaineHyperbaric marcaine 2.2 mL for spinal block | Drug | Hyperbaric Marcaine |
Primary outcome
Change of cardiac output (L/min) after spinal block
Time frame: 5 minutes after spinal block
The investigators will measure cardiac output using non-invasive methods (USCOM) before spinal block and 5 minutes after spinal block.
2 secondary outcomes
Total dose of vasopressor
Time frame: 2 hours
Number of patients who experience systolic blood pressure < 25% of preoperative measurement
Time frame: 2 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 31 Jul 2017.
- 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.
Sirilak Suksompong, MD principal investigator
Mahidol University
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 Isobaric marcaine and Hyperbaric marcaine in people with Cardiac Output and Hypotension, run by Mahidol University at 1 site in Thailand.
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 3 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 31 Jul 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 Thailand. 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?
Change of cardiac output (L/min) after spinal block (time frame: 5 minutes after spinal block). 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 31 Jul 2017.