Using Ondansetron to Prevent Itching in Cesarean Section Patients
Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus in Patients Undergoing Cesarean Section Under Spinal Anesthesia with Preservative Free Morphine.
This study tests if giving ondansetron can help prevent itching and nausea in women who have a cesarean section with spinal anesthesia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Wayne State University Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT06297499 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of ondansetron, a serotonin receptor antagonist, in preventing pruritus (itching) and nausea/vomiting in patients undergoing cesarean sections with spinal anesthesia. The study employs a randomized double-blinded approach to assess the impact of different timing for ondansetron administration on the incidence and severity of intrathecal morphine-induced pruritus. By focusing on a common side effect of spinal opioids, this research aims to improve postoperative care for cesarean delivery patients. The findings could provide valuable insights into managing side effects associated with opioid use in this population.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18-50 scheduled for elective cesarean delivery under spinal anesthesia with an ASA physical status of 1-3.
Not a fit: Patients with severe pre-existing conditions, allergies to the study medication, or those requiring alternative anesthesia techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of pruritus and nausea in cesarean section patients, enhancing their postoperative comfort and recovery.
How similar studies have performed: While the use of ondansetron for nausea and vomiting is well-established, this specific application for preventing pruritus in cesarean section patients is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Detroit, Michigan
- Detroit Medical Center- Hutzel Women's Hospital — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Justin Hruska, MD
- Email: justinhruska1@gmail.com
- Phone: 402-432-0985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.