Using Ondansetron to Prevent Itching in Cesarean Section Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.