Adverse Anesthesia OutcomeNCT02883192
The Effect of Preventive Use of Ondansetron in the Cesarean Section Under Spinal Anesthesia
A study testing Ondansetron in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- Ondansetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to Dec 2016
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesia (ASA) physical status I or II
Who cannot join
- Preeclampsia Cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Luis A Gaitini M.D.
Haifa
Luis A Gaitini, M.D., # 972 4 8359346, luis.gaitini@b-zion.org.il
About this study
Official title: The Effect of Preventive Use of Ondansetron on the Blood Pressure and Vasopressor Consumption in the Cesarean Section Under Spinal Anesthesia
Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population. The aim of the study is to investigate the effect of the preventive use of Ondansetron on the prevention of hypotension
Read the detailed description
Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia, in our Institute over than 90% of the elective cesarean sections are under spinal anesthesia, however this kind of anesthesia frequently associated with, side effects that affect primarily the parturient and the fetal health. The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population . Most authors agree that hypotension presents when the systolic blood pressure decrease under 90 mmHg, or when there is a reduction from baseline of more than 20-30 %. Augmentation of the intravascular volume with crystalloids and vasopressors is the cornerstone of the treatment of spinal anesthesia induced hypotension, the vasopressors usually used are the α and β receptors agonist ephedrine and the selective α agonist phenylephrine that, gain popularity in the last years, because it's more efficacy in maintaining the umbilical cord blood PH and the Apgar score of the neonates. However many studies showed that it was inefficient and no intervention reliably prevents hypotension after spinal anesthesia for cesarean section and, bradycardia can occur from shift in cardiac autonomic balance toward the parasympathetic system from activation of left ventricular mechanoreceptors after sudden decrease in left ventricle volume causing the Bezold Jarish Reflex (BJR). Animal studies suggest that 5-HT( serotonin) may play an important factor associated inducing the BJR and this effect can be blocked at the 5-HT3 receptor using the serotonin inhibitor Ondansetron, commonly used antiemetic . Despite the fact that Ondansetron was evaluated in the management of spinal anesthesia induced hypotension in large heterogeneity and small samples , the need for more investigation in big number of cesarean sections still needed.
The aim of the study is to investigate the effect of the preventive use of Ondansetron on the prevention of hypotension and the amount of vasopressor phenylephrine needed to control the hypotension after spinal anesthesia and the possible effect on the umbilical cord blood PH and the Apgar score in one minute after delivery.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Ondansetron, Placebo
- Keywords
- Cesarean section, spinal anesthesia, hypotension, ondansetron
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Zofran 4 mg.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ondansetron | Experimental | ondansetron Receives: Drug: Ondansetron |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measure in mmHg.
Measured: 40 minutes
Secondary outcomes (1)
Vomiting measure in number scale
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Anesthesia OutcomeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LUIS.GAITINI, Bnai Zion Medical Center
- Investigators
- mira koch, M.A., Study chair, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883192
- Sponsor's protocol ID
- BnaiZionMC-16-LG-011
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preventive Use of Ondansetron on the Blood Pressure and Vasopressor Consumption in the Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02883192
- Acronym / sponsor ID
- BnaiZionMC-16-LG-011
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Cesarean section, spinal anesthesia, hypotension, ondansetron
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 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.
Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population. The aim of the study is to investigate the effect of the preventive use of Ondansetron on the prevention of hypotension
Detailed description
Cesarean section is a frequent procedure in the obstetric surgery. The most widely used anesthesia technique for cesarean delivery is the spinal anesthesia, in our Institute over than 90% of the elective cesarean sections are under spinal anesthesia, however this kind of anesthesia frequently associated with, side effects that affect primarily the parturient and the fetal health. The incidence of spinal anesthesia induced hypotension and bradycardia is high as 60% in the obstetric population . Most authors agree that hypotension presents when the systolic blood pressure decrease under 90 mmHg, or when there is a reduction from baseline of more than 20-30 %. Augmentation of the intravascular volume with crystalloids and vasopressors is the cornerstone of the treatment of spinal anesthesia induced hypotension, the vasopressors usually used are the α and β receptors agonist ephedrine and the selective α agonist phenylephrine that, gain popularity in the last years, because it's more efficacy in maintaining the umbilical cord blood PH and the Apgar score of the neonates. However many studies showed that it was inefficient and no intervention reliably prevents hypotension after spinal anesthesia for cesarean section and, bradycardia can occur from shift in cardiac autonomic balance toward the parasympathetic system from activation of left ventricular mechanoreceptors after sudden decrease in left ventricle volume causing the Bezold Jarish Reflex (BJR). Animal studies suggest that 5-HT( serotonin) may play an important factor associated inducing the BJR and this effect can be blocked at the 5-HT3 receptor using the serotonin inhibitor Ondansetron, commonly used antiemetic . Despite the fact that Ondansetron was evaluated in the management of spinal anesthesia induced hypotension in large heterogeneity and small samples , the need for more investigation in big number of cesarean sections still needed.
The aim of the study is to investigate the effect of the preventive use of Ondansetron on the prevention of hypotension and the amount of vasopressor phenylephrine needed to control the hypotension after spinal anesthesia and the possible effect on the umbilical cord blood PH and the Apgar score in one minute after delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ondansetron | Experimental | Drug: Ondansetronondansetron |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesia (ASA) physical status I or II
Key exclusion criteria (1 listed)
- Preeclampsia Cardiovascular disease
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 |
|---|---|---|
| OndansetronAlso: ZofranZofran 4 mg. | Drug | ondansetron |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Blood pressure measure in mmHg.
Time frame: 40 minutes
1 secondary outcome
Vomiting measure in number scale
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
mira koch, M.A. study chair
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center at 1 site in Israel.
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 31 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis A Gaitini, M.D. (# 972 4 8359346, luis.gaitini@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measure in mmHg. (time frame: 40 minutes). 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 Aug 2016.