HypotensionPhase 3NCT04140058
Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section
A Phase 3 study testing Ondansetron and Normal saline in people with Hypotension and Nausea, run by University of Jordan at 1 site in Jordan.
Trial summary
Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Nausea, Vomiting
- What is being tested?
- Ondansetron and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteJordan
- Study dates
- 2 Jan 2016to 2 Jan 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who received spinal anesthesia for elective cesarean sections and meet the American Society of Anesthesiologist's (ASA) patient status classification I or II.
Who cannot join
- Patients ASA patient status classification III, IV or V
- Emergent cesarean sections
- Multiple parities (twins/triplets)
- More than 1,000 ml blood loss
- More than 6 mg ondansetron administered
- Patients presenting with a cardiac history (coronary artery disease, myocardial infarction, congestive heart failure, murmur, mitral valve prolapse/regurgitation, dysrhythmias, aortic stenosis/regurgitation)
- Patients presenting with preeclampsia
- Patients presenting for cesarean section with epidural due to failure to progress.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section, a Prospective, Randomized Double Blind Study
Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Prophylactic intravenous administration of ondansetron immediately and 5 minutes preoperatively have shown to provide a protective effect against hypotension while other studies have shown little effect on the incidence of blood pressure drop in healthy parturients.
The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.
Read the detailed description
This prospective randomized double-blind placebo-controlled study will include 150 American Society of Anaesthesiologist physical status grade I (ASA I) pregnant women scheduled for elective caesarean delivery under spinal anaesthesia.
Patients will be randomly allocated into three groups (n = 50) to receive intravenous ondansetron 4mg in 10 mL normal saline (group O4), 6 mg in 10 mL normal saline(group O6), or placebo of 10 mL normal saline (group C), all 15-20 minutes before spinal anaesthesia.
Hemodynamic variables and other adverse effects will be assessed at 16 time points intraoperatively. Those variables include blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, perioperative vasopressor requirements and patients' satisfaction.
Participants will be randomly allocated preoperatively as per randomizer.org software and will be blinded from other anaesthetists performing the spinal block and following patients intraoperatively.
- Conditions
- Hypotension, Nausea, Vomiting
- Being tested
- Ondansetron, Normal saline
- Keywords
- Ondansetron, hypotension, nausea and vomiting, cesarean section
- Medical subject headings
- Hypotension, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
ondansetron was administered 20 minutes prior to spinal anesthesia.
Normal salineDrug
Placebo of 10 mL normal saline was administered.
| Study group | Role | What they receive |
|---|---|---|
| group O4 | Active comparator | Patients received 4mg ondansetron. Receives: Drug: Ondansetron |
| group O6 | Active comparator | Patients received 6mg ondansetron. Receives: Drug: Ondansetron |
| group C | Placebo comparator | Patients received normal saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of Ondansetron prophylactically to prevent a significant decrease in systolic, diastolic, and mean blood pressure after the induction of spinal anaesthesia.
Baseline values of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Blood Pressure (MBP) were recorded. Ondansetron was given 15 minutes before induction of spinal anesthesia. After initiation of spinal anesthesia, the SBP, DBP, and MBP were recorded regularly until the end of the cesarean section by a blinded anaesthesiologist.
Measured: 1 year
Secondary outcomes (1)
Prevention of intraoperative nausea and vomiting.
Patients were assessed for nausea, and vomiting throughout the whole intraoperative period by asking and observing the patients for any signs and/or symptoms of nausea, and we recorded any incident of intraoperative vomiting using the following scale:
- no any complaint.
- mild degree of nausea.
- moderate degree of nausea and vomit.
- frequently vomit.
- severely (continuously vomit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start2 Jan 2016
- Primary completion2 Jan 2017
- Study completion2 Jan 2017
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhi M. Alghanem, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140058
- Sponsor's protocol ID
- 2433/2016/10
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifying information will be collected. Data will be used solely for statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section, a Prospective, Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT04140058
- Acronym / sponsor ID
- 2433/2016/10
- Conditions
- Hypotension, Nausea, Vomiting
- Keywords
- Ondansetron, hypotension, nausea and vomiting, cesarean section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 25 Oct 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.
Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Prophylactic intravenous administration of ondansetron immediately and 5 minutes preoperatively have shown to provide a protective effect against hypotension while other studies have shown little effect on the incidence of blood pressure drop in healthy parturients.
The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.
Detailed description
This prospective randomized double-blind placebo-controlled study will include 150 American Society of Anaesthesiologist physical status grade I (ASA I) pregnant women scheduled for elective caesarean delivery under spinal anaesthesia.
Patients will be randomly allocated into three groups (n = 50) to receive intravenous ondansetron 4mg in 10 mL normal saline (group O4), 6 mg in 10 mL normal saline(group O6), or placebo of 10 mL normal saline (group C), all 15-20 minutes before spinal anaesthesia.
Hemodynamic variables and other adverse effects will be assessed at 16 time points intraoperatively. Those variables include blood pressure, heart rate, oxygen saturation, nausea, vomiting, electrocardiographic changes, skin flushing, discomfort or pruritus, perioperative vasopressor requirements and patients' satisfaction.
Participants will be randomly allocated preoperatively as per randomizer.org software and will be blinded from other anaesthetists performing the spinal block and following patients intraoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group O4 | Active comparator | Drug: OndansetronPatients received 4mg ondansetron. |
| group O6 | Active comparator | Drug: OndansetronPatients received 6mg ondansetron. |
| group C | Placebo comparator | Drug: Normal salinePatients received normal saline. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who received spinal anesthesia for elective cesarean sections and meet the American Society of Anesthesiologist's (ASA) patient status classification I or II.
Key exclusion criteria (8 listed)
- Patients ASA patient status classification III, IV or V
- Emergent cesarean sections
- Multiple parities (twins/triplets)
- More than 1,000 ml blood loss
- More than 6 mg ondansetron administered
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 |
|---|---|---|
| Ondansetronondansetron was administered 20 minutes prior to spinal anesthesia. | Drug | group O4, group O6 |
| Normal salinePlacebo of 10 mL normal saline was administered. | Drug | group C |
Primary outcome
Usage of Ondansetron prophylactically to prevent a significant decrease in systolic, diastolic, and mean blood pressure after the induction of spinal anaesthesia.
Time frame: 1 year
Baseline values of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Blood Pressure (MBP) were recorded. Ondansetron was given 15 minutes before induction of spinal anesthesia. After initiation of spinal anesthesia, the SBP, DBP, and MBP were recorded regularly until the end of the cesarean section by a blinded anaesthesiologist.
1 secondary outcome
Prevention of intraoperative nausea and vomiting.
Time frame: 1 year
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 25 Oct 2019.
- Individual participant dataSharing planned: No. No identifying information will be collected. Data will be used solely for statistical analysis.
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.
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 3 study testing Ondansetron and Normal saline in people with Hypotension and Nausea, run by University of Jordan at 1 site in Jordan.
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 8 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 25 Oct 2019. 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 Jordan. 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?
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?
Usage of Ondansetron prophylactically to prevent a significant decrease in systolic, diastolic, and mean blood pressure after the induction of spinal anaesthesia. (time frame: 1 year). 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 25 Oct 2019.