HypotensionZORANCT02862873
Interest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section
A study testing Spinal anaesthesia, Ondansetron and saline solution in people with Hypotension, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- Spinal anaesthesia, Ondansetron and saline solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to May 2015
- Phase
- Interventional
- 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
- Persons who have provided written informed consent
- Persons with national health insurance cover
- Patients aged over 18 years, ASA I or II
- About to undergo scheduled or non-scheduled caesarean section under spinal anaesthesia
Who cannot join
- Adults under guardianship
- Contra indication for spinal anaesthesia (SA) (refusal, haemodynamic instability, innate or acquired coagulation disorder)
- History of hypersensitivity to Zophren or local anaesthetics
- Heart and/or kidney failure
- Treatment with angiotensin converting enzyme (ACE) inhibitor, Beta Blockers, or angiotensin II receptor antagonist (ARA II), Zophren, atropine, Selective Serotonin Reuptake Inhibitors, Triptans
- Caesarean in a context of extreme emergency, with a time to foetal extraction incompatible with SA and the injection of Zophren, (up to 30 minutes) and requiring consent in an emergency.
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- Pregnancy-related arterial hypertension (AHT)
- Pre-eclampsia
- Gestational diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iinterest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section: Double-blind Randomized Controlled Single-centre Study
The intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP).
The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates.
Read more
It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant.
One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses.
The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section.
The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.
- Conditions
- Hypotension
- Being tested
- Spinal anaesthesia, Ondansetron, saline solution
- Keywords
- Spinal anaesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anaesthesiaProcedure or surgery
OndansetronDrug
saline solutionOther
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Not described Receives: Procedure: Spinal anaesthesia; Drug: Ondansetron |
| Saline solution | Placebo comparator | Not described Receives: Procedure: Spinal anaesthesia; Other: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Systolic blood pressure below 90 mmHg
Measured: every 2 minutes from the intrathecal injection for 20 minutes, and then every 5 minutes until the end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2015
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 Centre Hospitalier Universitaire DijonThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862873
- Sponsor's protocol ID
- GIRARD WOLFF 2014
- Acronym
- ZORA
- Status last verified
- Jun 2016
- First submitted
- 4 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iinterest of Intravenous Ondansetron in the Prevention of Spinal Anaesthesia-induced Hypotension in Caesarean Section: Double-blind Randomized Controlled Single-centre Study
- ClinicalTrials.gov ID
- NCT02862873
- Acronym / sponsor ID
- ZORA / GIRARD WOLFF 2014
- Conditions
- Hypotension
- Keywords
- Spinal anaesthesia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- First posted
- 11 Aug 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 intravenous injection of 8mg of ondansetron (a serotonin type 3 receptor antagonist) before spinal anaesthesia for caesarean section, leads to a smaller reduction in systolic arterial pressure (SAP).
The expected results are a decrease in the frequency and severity of hypotension, thus leading to improved comfort for the mother and decreased maternal and foetal morbidity. Indeed, episodes of hypotension are responsible for impaired foeto-placental circulation, with sometimes severe consequences for neonates.
It has been established that episodes of hypotension alter foetal pH. Investigators therefore hope to see a smaller reduction in SAP in the ondansetron group, and show a benefit for the infant.
One of the objectives of this study is also to observe a decrease in the quantity of vasopressors used and thus to avoid the adverse effects of their use in high doses.
The expected results are thus an improvement in haemodynamic stability during spinal anaesthesia for caesarean section.
The originality of this project lies in the use of a CNAP monitor (Continuous Non-invasive Arterial Pressure) as the collection of haemodynamic data will allow greater precision with the continuous measurement of AP, as well as a study of maternal cardiac output.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Procedure: Spinal anaesthesia, Drug: Ondansetron |
| Saline solution | Placebo comparator | Procedure: Spinal anaesthesia, Other: saline solution |
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)
- Persons who have provided written informed consent
- Persons with national health insurance cover
- Patients aged over 18 years, ASA I or II
- About to undergo scheduled or non-scheduled caesarean section under spinal anaesthesia
Key exclusion criteria (9 listed)
- Adults under guardianship
- Contra indication for spinal anaesthesia (SA) (refusal, haemodynamic instability, innate or acquired coagulation disorder)
- History of hypersensitivity to Zophren or local anaesthetics
- Heart and/or kidney failure
- Treatment with angiotensin converting enzyme (ACE) inhibitor, Beta Blockers, or angiotensin II receptor antagonist (ARA II), Zophren, atropine, Selective Serotonin Reuptake Inhibitors, Triptans
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 |
|---|---|---|
| Spinal anaesthesia | Procedure or surgery | Ondansetron, Saline solution |
| Ondansetron | Drug | Ondansetron |
| saline solution | Other | Saline solution |
Primary outcome
number of Systolic blood pressure below 90 mmHg
Time frame: every 2 minutes from the intrathecal injection for 20 minutes, and then every 5 minutes until the end of the surgery.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anaesthesia, Ondansetron and saline solution in people with Hypotension, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 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: stopped early, as of the sponsor's last update on 11 Aug 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 France. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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 Systolic blood pressure below 90 mmHg (time frame: every 2 minutes from the intrathecal injection for 20 minutes, and then every 5 minutes until the end of the 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 11 Aug 2016.