Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting

Study Overview
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Brief Summary
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We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .

Detailed Description
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The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis. Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded. The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.

Official Title
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Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: ramosetron
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA American Society of Anesthesiologist (ASA) physical status I-III Giving written informed consent Exclusion Criteria: Body mass index (BMI) > 35 kg/m2 Unable to undergo spinal anesthesia History of allergic to study drugs Impaired renal and/or hepatic function Use of systemic steroids and anti-emetics within 24 hours of operation

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ramosetron group<br>Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine | Drug: ramosetron<br>* intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine<br>* Other names: ramosetorn;|
| Active Comparator: ondansetron group<br>Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine | Drug: Ondansetron<br>* intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of postoperative nausea and vomiting |  | 48 hours after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients require for anti-emetic medicine |  | 48 hours after the operation | 
| visual analog scale for pain |  | 48 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting