RECRUITING

Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus in Patients Undergoing Cesarean Section Under Spinal Anesthesia with Preservative Free Morphine.

Quick Facts

Study Start:2024-08-22
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06297499

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. American Society of Anesthesiologists (ASA) physical status 1-3
  2. 2. Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia
  3. 3. Patients must be willing and cognitively able to give written informed study consent
  1. 1. Patients with an ASA physiological assessment greater than grade 3
  2. 2. Allergies to local anesthetics, opioids, or ondansetron
  3. 3. Coagulopathies precluding provision of spinal anesthesia
  4. 4. Pre-eclampsia with severe features
  5. 5. Eclampsia
  6. 6. Pre-intrathecal pruritus
  7. 7. Psychiatric or language deficiencies affecting assessment of pain
  8. 8. Insufficient understanding of the pain scoring system
  9. 9. Patients who receive any other regional anesthesia techniques
  10. 10. Patients on higher than a 100mg of daily morphine equivalent
  11. 11. Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology.
  12. 12. Confounding neural issues that would preclude spinal anesthesia.
  13. 13. Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs.
  14. 14. Coadministration of drugs that would potentially prolong QTc interval. Including Antiarrhythmic, Antidepressants, Antipsychotics, and the following list of medications.
  15. 15. Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following:
  16. 16. Patients having the following
  17. 1. Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation
  18. 2. Concomitant use of apomorphine
  19. 3. History of QTc interval prolongation (QTc \>440) and Torsade de Pointes
  20. 4. Serotonin syndrome
  21. 5. Phenylketonuric patients
  22. 6. Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)

Contacts and Locations

Study Contact

Justin Hruska, MD
CONTACT
402-432-0985
justinhruska1@gmail.com
George M McKelvey, PhD
CONTACT
3135986036
geomckelvey@dmc.org

Study Locations (Sites)

Detroit Medical Center- Hutzel Women's Hospital
Detroit, Michigan, 48201
United States

Collaborators and Investigators

Sponsor: Wayne State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-08-22
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Cesarean Section
  • Intrathecal Morphine
  • Ondansetron

Additional Relevant MeSH Terms

  • Pruritus Caused by Drug