Recruiting
Phase 1

Ondansetron

Sponsor:

Wayne State University

Code:

NCT06297499

Conditions

Pruritus Caused by Drug

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Ondansetron 8mg

Study Details

Brief 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.

Conditions

Pruritus Caused by Drug

Study ID

NCT06297499

Start date

Aug 22, 2024

Status verified date

Mar, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Aug 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group 1. Pre-Intrathecal

Patients will receive an IV solution of 8mg ondansetron (4ml) within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by a placebo treatment of an IV solution of 4ml 0.9% saline administered at the time of umbilical cord clamping.

active comparator: Treatment Group 2 Cord clamping

Patients will receive a placebo treatment of an IV solution of 4ml 0.9% saline administered within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by an IV solution of 8mg ondansetron (4ml) administered at the time of umbilical cord clamping.

Interventions

Ondansetron 8mg

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

Primary outcome measure

  • Pruritus parameters in Post anesthesia Care Unit (PACU) [ Time Frame: Assessment during 1st post-operative hour in PACU ]
  • Pruritus severity in Post anesthesia Care Unit (PACU) [ Time Frame: Assessment during 1st post-operative hour in PACU ]
  • Pruritus parameters PACU [ Time Frame: Assessment during 24 hours post-operative period ]
  • Pruritus severity PACU [ Time Frame: Assessment during 24 hours post-operative period ]
  • Rescue Pruritus Treatment medication [ Time Frame: Measured in the 24 hour period from initial study treatment (30 minute period before intrathecal morphine administration. ]
  • Nausea PACU [ Time Frame: Assessment every 15 minutes for 1 hour ]
  • Nausea Post PACU [ Time Frame: our period after patients left PACU from initial study treatment (30 minute period before intrathecal morphine administration. ]

Central Contacts and Locations

Central contacts

Locations

Detroit Medical Center- Hutzel Women's Hospital

Recruiting

Detroit, Michigan, United States, 48201

Contacts

More Information

Sponsor

Wayne State University

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Keywords

  • Cesarean Section
  • Intrathecal Morphine
  • Ondansetron

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2025-03-28.