NCT06297499 Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
| NCT ID | NCT06297499 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Wayne State University |
| Condition | Pruritus Caused by Drug |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-08-22 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2024-08-22 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.
Eligibility Criteria
Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical status 1-3 2. Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia 3. Patients must be willing and cognitively able to give written informed study consent Exclusion Criteria: 1. Patients with an ASA physiological assessment greater than grade 3 2. Allergies to local anesthetics, opioids, or ondansetron 3. Coagulopathies precluding provision of spinal anesthesia 4. Pre-eclampsia with severe features 5. Eclampsia 6. Pre-intrathecal pruritus 7. Psychiatric or language deficiencies affecting assessment of pain 8. Insufficient understanding of the pain scoring system 9. Patients who receive any other regional anesthesia techniques 10. Patients on higher than a 100mg of daily morphine equivalent 11. Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology. 12. Confounding neural issues that would preclude spinal anesthesia. 13. Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs. 14. Coadministration of drugs that would potentially prolong QTc interval. Including Antiarrhythmic, Antidepressants, Antipsychotics, and the following list of medications. a. Levofloxacin, Ciprofloxacin, Gatifloxacin, Moxifloxacin, Clarithromycin, Erythromycin, Ketoconazole, Itraconazole, Cisapride, Sumatriptan, Zolmitriptan, Arsenic, Dolasetron, Methadone 15. Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following: a. Selective serotonin reuptake inhibitors, Serotonin and norepinephrine reuptake inhibitors, antidepressants, carbamazepine , valproic acid, triptans, Chronic pain medications prior to procedure (Fentanyl, Hydrocodone, Meperidine, Oxycodone, tramadol),Lithium, dextromethorphan, Linezolid and Ritonavir 16. Patients having the following 1. Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation 2. Concomitant use of apomorphine 3. History of QTc interval prolongation (QTc \>440) and Torsade de Pointes 4. Serotonin syndrome 5. Phenylketonuric patients 6. Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06297499 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Pruritus Caused by Drug. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06297499 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06297499 currently recruiting?
Yes, NCT06297499 is actively recruiting participants. Contact the research team at justinhruska1@gmail.com for enrollment information.
Where is the NCT06297499 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT06297499 clinical trial?
NCT06297499 is sponsored by Wayne State University. The trial plans to enroll 66 participants.