Spinal Induced HypotensionPhase 4NCT05127876
Ephedrine Versus Ondansetron During Cesarean Delivery
A Phase 4 study testing Ondansetron 4 MG, Ondansetron 8mg and EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution in people with Spinal Induced Hypotension, run by Ain Shams University at 1 site in Egypt.
Trial summary
More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Spinal Induced Hypotension
- What is being tested?
- Ondansetron 4 MG, Ondansetron 8mg and EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 6 Mar 2022
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age >18, <40 years;
- American Society of Anesthesiologists physical status I or II;
- term pregnancy
- singleton pregnancy;
- elective cesarean delivery under spinal anesthesia
Who cannot join
- Patients with a history of diabetes mellitus other than gestational diabetes,
- hypertension,
- body mass index >40 kg/m2,
- complicated pregnancy, allergy to study drugs,
- long QT syndrome,
- Contraindication to spinal anesthesia
- Patients who required general anesthesia were withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial
More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death.
The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.
Read the detailed description
Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery.
Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.
- Conditions
- Spinal Induced Hypotension
- Being tested
- Ondansetron 4 MG, Ondansetron 8mg, EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution, 10 mL normal saline
- Keywords
- cesarean section, Bezold-Jarisch reflex, ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 4 MGDrug
Also called Low dose ondansetron group
Ondansetron 4mg was given over 1 min, 5 min before spinal anesthesia
Ondansetron 8mgDrug
Also called Higher dose Ondanseteron group
Ondansetron 8mg was given over 1 min, 5 min before spinal anesthesia
EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous SolutionDrug
Also called Ephedrine group
Ephedrine 10mg was given over 1 min, 5 min before spinal anesthesia
10 mL normal salineOther
Also called Placebo group
10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group E | Experimental | Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. Receives: Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution |
| Group OL | Experimental | Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. Receives: Drug: Ondansetron 4 MG |
| Group OH | Experimental | Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. Receives: Drug: Ondansetron 8mg |
| Group P | Placebo comparator | Monitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.
Then under aseptic precautions, spinal anesthesia was administered. Receives: Other: 10 mL normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Maternal hypotension
Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min.
Measured: 45 minutes
Secondary outcomes (1)
Apgar score
1and 5 min after fetal delivery
Measured: 5 min after fetal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start10 Jan 2022
- Primary completion1 Mar 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- According to patients' randomized groups, study medication was given over 1 min, 5 min before spinal anesthesia Patients were randomly assigned into 1 of 4 groups, using computer generated sequence and opaque envelopes, according to the prophylactic intravenous drug dose used: * Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; * Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; * Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; * Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raham Hasan Mostafa, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127876
- Sponsor's protocol ID
- R 04 2022
- Status last verified
- Sep 2022
- First submitted
- 9 Nov 2021
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ephedrine Versus Ondansetron in the Prevention of Hypotension During Cesarean Delivery: a Randomized, Double Blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05127876
- Acronym / sponsor ID
- R 04 2022
- Conditions
- Spinal Induced Hypotension
- Keywords
- cesarean section, Bezold-Jarisch reflex, ondansetron
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 19 Nov 2021 (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.
More than 30% of the patients receiving spinal anesthesia develop hypotension. Hypotension developed during cesarean section (C/S) under spinal anesthesia may jeopardize uteroplacental circulation leading to fetal compromise and even fetal death.
The effect of prophylactic ondansetron on blood pressure after spinal anesthesia has not been compared in a clinical trial with that of a vasoconstrictor. The investigators will compare ephedrine and ondansetron for the prevention of maternal hypotension after spinal anesthesia for elective cesarean delivery.
Detailed description
Some vasopressive drugs including ephedrine and phenylephrine have been widely used to prevent maternal hypotension. Although ephedrine has mixed a-adrenoceptor activity , it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors. It has been demonstrated that ondansetron preloading with crystalloid infusion reduces maternal hypotension in parturient women undergoing cesarean delivery.
Ondansetron has been widely used in the clinic to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron has been proven as a well-tolerated drug, but the most common side effects of ondansetron include headache, constipation, diarrhea, asthenia, and somnolence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- According to patients' randomized groups, study medication was given over 1 min, 5 min before spinal anesthesia Patients were randomly assigned into 1 of 4 groups, using computer generated sequence and opaque envelopes, according to the prophylactic intravenous drug dose used: * Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; * Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; * Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; * Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo.
| Arm | Type | Receives |
|---|---|---|
| Group E | Experimental | Drug: EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous SolutionMonitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group E: were administered intravenous ephedrine 10 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. |
| Group OL | Experimental | Drug: Ondansetron 4 MGMonitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OL: were administered intravenous ondansetron 4 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. |
| Group OH | Experimental | Drug: Ondansetron 8mgMonitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group OH: were administered intravenous ondansetron 8 mg diluted in 10 mL 0.9% saline over 1 minute; Then under aseptic precautions, spinal anesthesia was administered. |
| Group P | Placebo comparator | Other: 10 mL normal salineMonitoring with pulse oximetry, noninvasive blood pressure measurement and electrocardiogram was established on arrival to the operating room Group P: was a control group who received 0.9% saline 10 mL over 1 minute as a placebo. Then under aseptic precautions, spinal anesthesia was administered. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age >18, <40 years;
- American Society of Anesthesiologists physical status I or II;
- term pregnancy
- singleton pregnancy;
- elective cesarean delivery under spinal anesthesia
Key exclusion criteria (7 listed)
- Patients with a history of diabetes mellitus other than gestational diabetes,
- hypertension,
- body mass index >40 kg/m2,
- complicated pregnancy, allergy to study drugs,
- long QT syndrome,
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 4 MGAlso: Low dose ondansetron groupOndansetron 4mg was given over 1 min, 5 min before spinal anesthesia | Drug | Group OL |
| Ondansetron 8mgAlso: Higher dose Ondanseteron groupOndansetron 8mg was given over 1 min, 5 min before spinal anesthesia | Drug | Group OH |
| EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous SolutionAlso: Ephedrine groupEphedrine 10mg was given over 1 min, 5 min before spinal anesthesia | Drug | Group E |
| 10 mL normal salineAlso: Placebo group10 mL normal salinwe 0.9% was given over 1 min, 5 min before spinal anesthesia | Other | Group P |
Primary outcome
Incidence of Maternal hypotension
Time frame: 45 minutes
Mean arterial blood pressure was recorded every 2 minute for 10 minutes then every 5 minutes until delivery. Time of intrathecal injection was considered as 0 min.
1 secondary outcome
Apgar score
Time frame: 5 min after fetal delivery
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 9 Sep 2022.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
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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 Phase 4 study testing Ondansetron 4 MG, Ondansetron 8mg and EPHEDrine 10 Mg/mL-NaCl 0.9% Intravenous Solution in people with Spinal Induced Hypotension, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 7 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 9 Sep 2022. 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 Egypt. 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?
Incidence of Maternal hypotension (time frame: 45 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 9 Sep 2022.