Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

Study Overview
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Brief Summary
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Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

Detailed Description
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Intrathecal administration of morphine is often used for relief of postoperative pain. However, pruritus is one of the most common side effects associated with intrathecal morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

Official Title
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Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

Conditions
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Morphine Adverse Reaction

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Palonosetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-70 years, American Society of Anesthesiology physical status 1 and 2 Scheduled for elective urologic surgery under spinal anesthesia. Exclusion Criteria: Patients with cardiac and psychological problems. Patients who take sedatives or narcotics. Patient who have allergy to study drugs.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ondansetron<br>Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia | Drug: Ondansetron<br>* intravenous injection<br>* Other names: zofran;|
| Experimental: palonosetron<br>Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia | Drug: Palonosetron<br>* intravenous injection<br>* Other names: aloxi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pruritus | record of the incidence of pruritus after spinal anesthsia | 24 hours after spinal anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrathecal, morphine, ondansetron, palonosetron, pruritus