Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
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|ClinicalTrials.gov Identifier: NCT02830906|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: ramosetron Drug: Ondansetron||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
Experimental: ramosetron group
Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine
intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine
Other Name: ramosetorn
Active Comparator: ondansetron group
Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine
intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine
- Incidence rate of postoperative nausea and vomiting [ Time Frame: 48 hours after the operation ]
- number of patients require for anti-emetic medicine [ Time Frame: 48 hours after the operation ]
- visual analog scale for pain [ Time Frame: 48 hours after operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830906
|Principal Investigator:||piya pinsornsak, md||Thammasat University|