Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06297499

PHASE1

Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

Sponsor: Wayne State University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-22

Completion Date

2025-12-01

Last Updated

2025-03-28

Healthy Volunteers

Yes

Conditions

Pruritus Caused by Drug

Interventions

DRUG

Ondansetron 8mg

administration of an IV solution of 8mg ondansetron (4ml)

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)

Locations (1)

Detroit Medical Center- Hutzel Women's Hospital

Detroit, Michigan, United States