Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

NCT06297499 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB-22-07-4803
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

Cesarean Section; Intrathecal Morphine; Ondansetron

Outcome Measures

Primary Outcomes (7)

• Pruritus parameters in Post anesthesia Care Unit (PACU)

  Patient Assessment (patient questionnaire): Pruritus occurrence (Yes or no) and anatomical location of Pruritus of occurrence, Severity of Pruritus- Likert scale choices from (Not present, Mild, Moderate, Severe, Unbearable) severity

  Assessment during 1st post-operative hour in PACU

• Pruritus severity in Post anesthesia Care Unit (PACU)

  Severity of Pruritus- Likert scale choices from (Not present, Mild, Moderate, Severe, Unbearable) severity

  Assessment during 1st post-operative hour in PACU

• Pruritus parameters PACU

  Patient Assessment (patient questionnaire): Pruritus occurrence (Yes or no) and anatomical location of pruritus location

  Assessment during 24 hours post-operative period

• Pruritus severity PACU

  Patient Assessment (patient questionnaire): Pruritus Severity: Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)

  Assessment during 24 hours post-operative period

• Rescue Pruritus Treatment medication

  Patient Assessment questionnaire: If rescue Pruritus treatment was required (YES/NO) and if so specific medication type and dose amount of medication

  Measured in the 24 hour period from initial study treatment (30 minute period before intrathecal morphine administration.

• Nausea PACU

  Patient Assessment questionnaire: Severity of Nausea- Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)

  Assessment every 15 minutes for 1 hour

• Nausea Post PACU

  Patient Assessment questionnaire: Severity of Nausea- Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)

  our period after patients left PACU from initial study treatment (30 minute period before intrathecal morphine administration.

Secondary Outcomes (1)

• Post-operative Pain

  Taken while patient in PACU at 0 minutes, 15 minutes, 30 minutes, 45 minutes and 60 min. Post PACU patient assessment at at 8 hours, 16 hours, 24 hours post-operative period

Other Outcomes (8)

• Peripheral oxygen saturation- Mother

  At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery

• Peripheral oxygen saturation- Infant

  At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery

• Heart rate- Mother

  At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery

Study Arms (2)

Treatment Group 1. Pre-Intrathecal

EXPERIMENTAL

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.

Drug: Ondansetron 8mg

Treatment Group 2 Cord clamping

ACTIVE COMPARATOR

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.

Drug: Ondansetron 8mg

Interventions

Ondansetron 8mg DRUG

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

Also known as: Placebo- 4ml of 0.9% IV saline

Treatment Group 1. Pre-Intrathecal; Treatment Group 2 Cord clamping

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Detroit Medical Center- Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Interventions

Ondansetron; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Justin Hruska, MD

CONTACT

402-432-0985; justinhruska1@gmail.com

George M McKelvey, PhD

CONTACT

3135986036; geomckelvey@dmc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized double-blinded trial

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 7, 2024
• Study Start: August 22, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)