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Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

Wayne State University · NCT06297499

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–50 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
66
US sites recruiting
1
Study start
August 22, 2024
Record last updated
March 28, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Ondansetron 8mg

Conditions: Pruritus Caused by Drug

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia
  • Patients must be willing and cognitively able to give written informed study consent

Exclusion Criteria

  • Patients with an ASA physiological assessment greater than grade 3
  • Allergies to local anesthetics, opioids, or ondansetron
  • Coagulopathies precluding provision of spinal anesthesia
  • Pre-eclampsia with severe features
  • Eclampsia
  • Pre-intrathecal pruritus
  • Psychiatric or language deficiencies affecting assessment of pain
  • Insufficient understanding of the pain scoring system
  • Patients who receive any other regional anesthesia techniques
  • Patients on higher than a 100mg of daily morphine equivalent
  • Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology.
  • Confounding neural issues that would preclude spinal anesthesia.
  • Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs.
  • 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

  • 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

  • Patients having the following
  • Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation
  • Concomitant use of apomorphine
  • History of QTc interval prolongation (QTc >440) and Torsade de Pointes
  • Serotonin syndrome
  • Phenylketonuric patients
  • Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)

Recruiting US locations

  • Detroit Medical Center- Hutzel Women's Hospital

    Detroit, MI 48201

    Site contact: George M McKelvey, PhD · 3135986036 · gmckelve@dmc.org

Study contacts (from the official record)

  • Justin Hruska, MD · 402-432-0985 · justinhruska1@gmail.com
  • George M McKelvey, PhD · 3135986036 · geomckelvey@dmc.org
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Ondansetron Use for Preventing Pruritus in Patients Undergoing… (NCT06297499) | Bored Studies