BridgeMD
New treatment option for Pruritus Caused by Drug
Official title Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
ClinicalTrials.gov ID: NCT06297499
What this study is testing
What is Ondansetron 8mg?
Ondansetron 8mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pruritus caused by drug.
Also referred to as Placebo- 4ml of 0.9% IV saline.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.