PruritusNCT02793843
Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section
A study testing Ondansetron (Zofran), Dexamethasone (Decadron) and Spinal anesthesia in people with Pruritus and Cesarean Section, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Pruritus, Cesarean Section
- What is being tested?
- Ondansetron (Zofran), Dexamethasone (Decadron) and Spinal anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteLebanon
- Study dates
- Jun 2016to 30 Jul 2017
- 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiology physical status 1 and 2
- Scheduled for elective c-section surgery under spinal anesthesia
Who cannot join
- Patients with cardiac and psychological problems
- Patients who take sedatives or narcotics
- Patient who have allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section
Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus.
Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV).
Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.
Read the detailed description
A prospective randomized double blind study will be conducted between June 2016 and June 2017. The sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. After obtaining informed consent, all eligible patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV) ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg (2 ml) dexamethasone.
- Conditions
- Pruritus, Cesarean Section
- Being tested
- Ondansetron (Zofran), Dexamethasone (Decadron), Spinal anesthesia
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron (Zofran)Drug
Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia
Dexamethasone (Decadron)Drug
Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia
Spinal anesthesiaOther
Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Active comparator | Not described Receives: Drug: Ondansetron (Zofran); Other: Spinal anesthesia |
| Ondansetron+ dexamethasone | Experimental | Not described Receives: Drug: Ondansetron (Zofran); Drug: Dexamethasone (Decadron); Other: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus assessed through questionnaire
Measured: 24 hours postoperatively
Secondary outcomes (1)
Post operative nausea and vomiting assessed through questionnaire
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion15 Jun 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793843
- Sponsor's protocol ID
- 2432016
- Status last verified
- Nov 2017
- First submitted
- 3 Jun 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section
- ClinicalTrials.gov ID
- NCT02793843
- Acronym / sponsor ID
- 2432016
- Conditions
- Pruritus, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 8 Jun 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.
Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus.
Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV).
Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.
Detailed description
A prospective randomized double blind study will be conducted between June 2016 and June 2017. The sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. After obtaining informed consent, all eligible patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV) ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg (2 ml) dexamethasone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Active comparator | Drug: Ondansetron (Zofran), Other: Spinal anesthesia |
| Ondansetron+ dexamethasone | Experimental | Drug: Ondansetron (Zofran), Drug: Dexamethasone (Decadron), Other: Spinal anesthesia |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology physical status 1 and 2
- Scheduled for elective c-section surgery under spinal anesthesia
Key exclusion criteria (3 listed)
- Patients with cardiac and psychological problems
- Patients who take sedatives or narcotics
- Patient who have allergy to study drugs
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 (Zofran)Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia | Drug | Ondansetron, Ondansetron+ dexamethasone |
| Dexamethasone (Decadron)Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia | Drug | Ondansetron+ dexamethasone |
| Spinal anesthesiaIntrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle) | Other | Ondansetron, Ondansetron+ dexamethasone |
Primary outcome
Pruritus assessed through questionnaire
Time frame: 24 hours postoperatively
1 secondary outcome
Post operative nausea and vomiting assessed through questionnaire
Time frame: 24 hours postoperatively
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 6 Nov 2017.
- Individual participant dataSharing planned: No
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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 study testing Ondansetron (Zofran), Dexamethasone (Decadron) and Spinal anesthesia in people with Pruritus and Cesarean Section, run by Makassed General Hospital at 1 site in Lebanon.
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 2 inclusion and 3 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 6 Nov 2017. 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 Lebanon. 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. 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?
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?
Pruritus assessed through questionnaire (time frame: 24 hours postoperatively). 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 6 Nov 2017.