Caesarean SectionPhase 4ODPNCT05583214
Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia
A Phase 4 study testing Ondansetron 8mg, Dexamethasone 8mg and Normal saline in people with Caesarean Section and Spinal Anesthesia, run by Muhammad Mubariz at 1 site in Pakistan.
Trial summary
The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section, Spinal Anesthesia
- What is being tested?
- Ondansetron 8mg, Dexamethasone 8mg and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2022to Jan 2023
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age above 20 but less than 35 years old
- Given informed consent
- No contraindication to spinal anesthesia
- ASA I or II
Who cannot join
- Age less than 20 or more than 35 years old
- Non-consenting
- Contraindication to spinal anesthesia
- ASA III or IV
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Akhtar Saeed Trust Hospital
Lahore, Punjab Province, 53710
Raheel, +92 3211415063, principal@amdc.edu.pk
Muhammad Mubariz, MBBS
About this study
Official title: Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia
The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:
Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.
Read more
Which drug is the best at reducing intraoperative pain.
Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.
A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.
Data collected from the three groups will be analyzed using SPSS software.
- Conditions
- Caesarean Section, Spinal Anesthesia
- Being tested
- Ondansetron 8mg, Dexamethasone 8mg, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia
Dexamethasone 8mgDrug
8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia
Normal salineDrug
Normal saline will be given IV stat to the group after induction of spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Patients given Ondansetron (8mg) Receives: Drug: Ondansetron 8mg |
| Dexamethasone | Experimental | Patients given Dexamethasone (8mg) Receives: Drug: Dexamethasone 8mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative nausea
Measured by an 11-point numeric rating scale
Measured: 20 minutes after initiation of procedure
Intraoperative vomiting
Number of episodes of vomiting throughout the procedure
Measured: 1 hour
Secondary outcomes (1)
Intraoperative pain
Measured by an 11-point numeric rating scale
Measured: 20 minutes after the initiation of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Mubariz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Mubariz, Akhtar Saeed Medical and Dental College
- Investigators
- Muhammad Mubariz, MBBS, Principal investigator, House Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583214
- Sponsor's protocol ID
- UMO708991
- Acronym
- ODP
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient's consent form, MR number Detailed rating scale data Intraoperative blood pressure and heart rate data
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05583214
- Acronym / sponsor ID
- ODP / UMO708991
- Conditions
- Caesarean Section, Spinal Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Muhammad MubarizUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 17 Oct 2022 (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 goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:
Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.
Which drug is the best at reducing intraoperative pain.
Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.
A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.
Data collected from the three groups will be analyzed using SPSS software.
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 |
|---|---|---|
| Ondansetron | Experimental | Drug: Ondansetron 8mgPatients given Ondansetron (8mg) |
| Dexamethasone | Experimental | Drug: Dexamethasone 8mgPatients given Dexamethasone (8mg) |
| Placebo | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age above 20 but less than 35 years old
- Given informed consent
- No contraindication to spinal anesthesia
- ASA I or II
Key exclusion criteria (4 listed)
- Age less than 20 or more than 35 years old
- Non-consenting
- Contraindication to spinal anesthesia
- ASA III or IV
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 8mg8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia | Drug | Ondansetron |
| Dexamethasone 8mg8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia | Drug | Dexamethasone |
| Normal salineNormal saline will be given IV stat to the group after induction of spinal anesthesia | Drug | Placebo |
Primary outcome
Intraoperative nausea
Time frame: 20 minutes after initiation of procedure
Measured by an 11-point numeric rating scale
Intraoperative vomiting
Time frame: 1 hour
Number of episodes of vomiting throughout the procedure
1 secondary outcome
Intraoperative pain
Time frame: 20 minutes after the initiation of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: Yes. Patient's consent form, MR number Detailed rating scale data Intraoperative blood pressure and heart rate data
Related trials for Caesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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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.
Muhammad Mubariz, MBBS principal investigator
House Officer
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 8mg, Dexamethasone 8mg and Normal saline in people with Caesarean Section and Spinal Anesthesia, run by Muhammad Mubariz at 1 site in Pakistan.
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 4 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 18 Oct 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Mubariz, MBBS (+923364241055, mubariz1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative nausea (time frame: 20 minutes after initiation of procedure). 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 18 Oct 2022.