Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ramosetron
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ramosetron group
ondansetron group
Arm Description
Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine
Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine
Outcomes
Primary Outcome Measures
Incidence rate of postoperative nausea and vomiting
Secondary Outcome Measures
number of patients require for anti-emetic medicine
visual analog scale for pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02830906
Brief Title
Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Total Knee Arthroplasty, Intrathecal Morphine, Ramosetron, Ondansetron, postoperative nausea and vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ramosetron group
Arm Type
Experimental
Arm Description
Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine
Arm Title
ondansetron group
Arm Type
Active Comparator
Arm Description
Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
ramosetron
Other Intervention Name(s)
ramosetorn
Intervention Description
intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine
Primary Outcome Measure Information:
Title
Incidence rate of postoperative nausea and vomiting
Time Frame
48 hours after the operation
Secondary Outcome Measure Information:
Title
number of patients require for anti-emetic medicine
Time Frame
48 hours after the operation
Title
visual analog scale for pain
Time Frame
48 hours after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
piya pinsornsak, md
Organizational Affiliation
Thammasat University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
We'll reach out to this number within 24 hrs