HypotensionPhase 3NCT03931863
The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
A Phase 3 study testing Ondansetron 4mg, Ondansetron 8mg and 100ml normal saline 0.9 percent in people with Hypotension, run by Aretaieion University Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- Ondansetron 4mg, Ondansetron 8mg and 100ml normal saline 0.9 percent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- 22 May 2019to May 2022
- Phase
- Phase 3
- 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
- Physical status according to American Society of Anesthesiologists (ASA) I-II
- Singleton pregnant women in full term pregnancy
- Patients scheduled for cesarean section
- Height 158cm-170cm
Who cannot join
- patient's own refusal
- contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics)
- ondansetron allergy
- body mass index> 33kg / m^2
- height <158cm, or> 170cm
- hypertensive disorders of pregnancy
Show all 9Show fewer
- cardiovascular disease
- receiving selective serotonin reuptake inhibitors (SSRI's) or treatment for migraine
- placenta previa.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieio Hospital, University of Athens
Athens, Attica, 11528
Anteia Paraskeva, MD, +306972868078, aparask@med.uoa.gr
Anteia Paraskeva, MD
About this study
The purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.
Read the detailed description
The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include electrocardiography (ECG), noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). Two peripheral intravenous catheters wil be placed for fluid replacement and administration of drugs.
Participants will be randomly assigned to one of the following groups:
Group A: Women will receive 4 milligrams (mg) of ondansetron diluted in 100 milliliters (ml) of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Group B:Women will receive 8 mg of ondansetron diluted in 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Group C:Women will receive 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Subsequently, after receiving 500ml of colloid solution, spinal anesthesia will be performed at level L3-L4 or L4-L5 in the vertebral space with 1.6ml of 0.75 percent ropivacaine and 15mcg of fentanyl, using a 27-gauge pencil point spinal needle with patients in a left lateral position. After subarachnoid infusion, participants will be placed supine with left uterine displacement and anesthetic and motor blockage will be evaluated every one minute until anesthetic blockage reaches the level of T4 neurotome and the motor block becomes complete (Bromage grade 3). This time will be called Time to max effect (Tmax).
Hypotension, defined as systolic blood pressure below 100 millimeters of Mercury (mmHg), will be treated using 5mg ephedrine if the heart rate is less than 100 beats per minute or with 20mcg of phenylephrine if the heart rate is greater than 100 beats per minute. Bradycardia, defined as a fall in heart rate below 60 beats per minute will be treated with atropine (0.6mg).
Immediately after the delivery of the neonate, all women will receive a solution of oxytocin (20 units) intravenously. Half an hour before the end of the procedure they will receive an additional 1g of paracetamol and 75mg of diclofenac.
- Conditions
- Hypotension
- Being tested
- Ondansetron 4mg, Ondansetron 8mg, 100ml normal saline 0.9 percent
- Keywords
- ondansetron
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4mgDrug
Also called Onda
Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
Ondansetron 8mgDrug
Also called Onda
Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
100ml normal saline 0.9 percentDrug
Also called N/S 0.9 percent
Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. Receives: Drug: Ondansetron 4mg |
| Group B | Active comparator | Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. Receives: Drug: Ondansetron 8mg |
| Group C | Placebo comparator | Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. Receives: Drug: 100ml normal saline 0.9 percent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Systolic Blood Pressure during cesarean section
every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery
Measured: 60 minutes
Change from Baseline Heart Rate
every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery
Measured: 60 minutes
Secondary outcomes (15)
Sensory blockade
Time for onset of sensory block at T4
Measured: 20 minutes
Motor blockade
Time to Bromage 2 and to Bromage 3
Measured: 20 minutes
Sensory regression
Time to two segment regression
Measured: 120 minutes
Motor block regression
Time to Bromage 1 and Bromage 0
Measured: 120 minutes
Time to maximum effect (Tmax)
Time when the motor blockade is complete and sensory blockade is in at the level of T4 dermatome
Measured: 20 minutes
Time to minimum effect (Tmin)
Time to two segment regression of the sensory block (T6) and for motor block regression to Bromage1 and Bromage 0
Measured: 120 minutes
Nausea
Scale for nausea (0:no nausea 10:worst possible nausea)
Measured: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Vomiting
Number of vomits
Measured: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Shivering
Yes:shiver No:no shiver
Measured: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Total ephedrine consumption
Total ephedrine consumption intraoperatively
Measured: 60 minutes
Total phenylephrine consumption
Total phenylephrine consumption intraoperatively
Measured: 60 minutes
Total atropine consumption
Total atropine consumption intraoperatively
Measured: 60 minutes
Neonate Apgar score
Apgar score in the 1st and 5th minute after delivery of the neonate
Measured: 5 minutes
Umbilical cord ph
Umbilical cord ph after delivery
Measured: 15 minutes
Need for administration of antiemetic agent
Need for administration of antiemetic agent intraoperatively
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start22 May 2019
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens
- Responsible party
- Principal investigator, Stavroula Karachanidi, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931863
- Sponsor's protocol ID
- 124/17-04-2019
- Status last verified
- Jan 2021
- First submitted
- 24 Apr 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ondansetron on Spinal Anesthesia in Caesarean Section
- ClinicalTrials.gov ID
- NCT03931863
- Acronym / sponsor ID
- 124/17-04-2019
- Conditions
- Hypotension
- Keywords
- ondansetron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Collaborators
- University of Athens
- Study start
- 22 May 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 30 Apr 2019 (actual)
- 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 administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. Apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.
Detailed description
The day before surgery the procedure will be explained to the patient and the written consent will be obtained. In the operating room, intraoperative monitoring will include electrocardiography (ECG), noninvasive blood pressure, oxygen saturation by pulse oximetry (SpO2) and heart rate (HR). Two peripheral intravenous catheters wil be placed for fluid replacement and administration of drugs.
Participants will be randomly assigned to one of the following groups:
Group A: Women will receive 4 milligrams (mg) of ondansetron diluted in 100 milliliters (ml) of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Group B:Women will receive 8 mg of ondansetron diluted in 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Group C:Women will receive 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia
Subsequently, after receiving 500ml of colloid solution, spinal anesthesia will be performed at level L3-L4 or L4-L5 in the vertebral space with 1.6ml of 0.75 percent ropivacaine and 15mcg of fentanyl, using a 27-gauge pencil point spinal needle with patients in a left lateral position. After subarachnoid infusion, participants will be placed supine with left uterine displacement and anesthetic and motor blockage will be evaluated every one minute until anesthetic blockage reaches the level of T4 neurotome and the motor block becomes complete (Bromage grade 3). This time will be called Time to max effect (Tmax).
Hypotension, defined as systolic blood pressure below 100 millimeters of Mercury (mmHg), will be treated using 5mg ephedrine if the heart rate is less than 100 beats per minute or with 20mcg of phenylephrine if the heart rate is greater than 100 beats per minute. Bradycardia, defined as a fall in heart rate below 60 beats per minute will be treated with atropine (0.6mg).
Immediately after the delivery of the neonate, all women will receive a solution of oxytocin (20 units) intravenously. Half an hour before the end of the procedure they will receive an additional 1g of paracetamol and 75mg of diclofenac.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Ondansetron 4mgIntravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. |
| Group B | Active comparator | Drug: Ondansetron 8mgIntravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. |
| Group C | Placebo comparator | Drug: 100ml normal saline 0.9 percentIntravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Physical status according to American Society of Anesthesiologists (ASA) I-II
- Singleton pregnant women in full term pregnancy
- Patients scheduled for cesarean section
- Height 158cm-170cm
Key exclusion criteria (9 listed)
- patient's own refusal
- contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics)
- ondansetron allergy
- body mass index> 33kg / m^2
- height <158cm, or> 170cm
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 |
|---|---|---|
| Ondansetron 4mgAlso: OndaIntravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. | Drug | Group A |
| Ondansetron 8mgAlso: OndaIntravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. | Drug | Group B |
| 100ml normal saline 0.9 percentAlso: N/S 0.9 percentIntravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia. | Drug | Group C |
Primary outcome
Change from Baseline Systolic Blood Pressure during cesarean section
Time frame: 60 minutes
every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery
Change from Baseline Heart Rate
Time frame: 60 minutes
every one minute after spinal anaesthesia and every five minutes after the delivery of the neonate until the end of the surgery
15 secondary outcomes
Sensory blockade
Time frame: 20 minutes
Motor blockade
Time frame: 20 minutes
Sensory regression
Time frame: 120 minutes
Motor block regression
Time frame: 120 minutes
Time to maximum effect (Tmax)
Time frame: 20 minutes
Time to minimum effect (Tmin)
Time frame: 120 minutes
Nausea
Time frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Vomiting
Time frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Shivering
Time frame: 0 hours, 2 hours, 4 hours, 8 hours, 24 hours postoperatively
Total ephedrine consumption
Time frame: 60 minutes
Total phenylephrine consumption
Time frame: 60 minutes
Total atropine consumption
Time frame: 60 minutes
Neonate Apgar score
Time frame: 5 minutes
Umbilical cord ph
Time frame: 15 minutes
Need for administration of antiemetic agent
Time frame: 90 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Related trials for Hypotension
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron 4mg, Ondansetron 8mg and 100ml normal saline 0.9 percent in people with Hypotension, run by Aretaieion University Hospital at 1 site in Greece.
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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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 Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stavroula Karachanidi (+306970253686, skarahanidi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Systolic Blood Pressure during cesarean section (time frame: 60 minutes). The study lists 2 primary outcomes in all. 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 20 Jan 2021.