Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

ConditionPruritus Caused by Drug

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18-50

SponsorWayne State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

66 Participants

are divided into 2 treatment groups

Group A: Treatment Group 1. Pre-IntrathecalExperimental treatment 1 intervention

Group B: Treatment Group 2 Cord clampingActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

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

Time frame

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)

Time frame

Assessment during 24 hours post-operative period

Secondary outcomes

Post-operative Pain

Patient assessment questionnaire: Visual analog pain scale (VAS) measuring scores from 0 (no pain)-10 (worst pain) at rest

Time frame

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

Peripheral oxygen saturation- Mother

Clinical Measurement of patient Peripheral blood oxygen saturation (percentage %) via a pulse oximeter

Time frame

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

Peripheral oxygen saturation- Infant

Clinical Measurement of patient Peripheral blood oxygen saturation (percentage %) via a pulse oximeter

Time frame

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

Heart rate- Mother

Clinical Measurement of patient heart rate (beats per minute) via a pulse oximeter

Time frame

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

Heart rate- Infant

Clinical Measurement of patient heart rate (beats per minute) via a pulse oximeter

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

Source ClinicalTrials.gov

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