Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis, Knee focused on measuring postoperative nausea and vomiting
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary osteoarthritis, knee
- Scheduled for elective total knee arthroplasty
- Signed written informed consent
Exclusion Criteria:
- Refusing participate
- Contraindication to regional anesthesia
- Severe impairment of bowel motility
- administration of other antiemetics within 24hours before surgery
- systemic steroid within 24hours before surgery
- history of cardiovascular & respiratory disease
- renal & hepatic failure
Sites / Locations
- Joint Reconstruction Center, Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ramosetron prophylaxis
Control
Arm Description
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
no antiemetic prophylaxis
Outcomes
Primary Outcome Measures
Incidence of Nausea and Vomiting
outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting
Secondary Outcome Measures
Incidence of Rescue Antiemetic Administration
outcome assessor assessed the incidence of rescue antiemetic administration
Full Information
NCT ID
NCT01102491
First Posted
April 8, 2010
Last Updated
June 3, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01102491
Brief Title
Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty
Official Title
The Effect of Multimodal Anti-emetic Protocol on Postoperative Nausea and Vomiting After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purposes of this study are to document the antiemetic efficacy of multimodal antiemetic protocol in patient after Total Knee Arthroplasty using regional anesthesia, midazolam & propofol, hydration & oxygen supplement, preemptive & multimodal contemporary pain management and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect on this protocol. We hypothesized that the incidence of Postoperative nausea and vomiting during multimodal antiemetic protocol would be lower than Apfel's expected postoperative nausea and vomiting incidence. It was also hypothesized that Ramosetron prophylaxis would provide additional antiemetic effect.
Detailed Description
Immediate postoperative pain after Total Knee Arthroplasty(TKA) remains an unsolved problem, and a substantial proportion of patients experience moderate to severe postoperative pain. Patient controlled analgesia(PCA) using opioid is an effective and safe modality for postoperative pain relief after TKA and remains an integral part of pain management after TKA. However, Opioid is associated with high incidence of postoperative nausea and vomiting(PONV) which is the most frequent complication during the first 24 hour after surgery.PONV has been reported to be more distressing than postoperative pain and to be the most undesirable negative outcome. Despite advances in prevention and treatment of PONV, PONV remains a continuing problem with an incidence of 20-30% in unselected patients and up to 70% in "high-risk" patients. As results of current researches, some risk factors of PONV have been identified and indications of prophylactic antiemetics and strategies to reduce baseline risk have been recommended.The recommended modalities to reduce baseline risk includes regional anesthesia, oxygen supplement, use of midazolam and propofol and avoid use of inhaled anesthesia and neuromuscular blockade. In addition,published evidence suggests that appropriate antiemetic prophylaxis should be considered for patients with 2 or more risk factors and to reduce opioid consumption, preemptive multimodal pain management such as preemptive analgesic medication, continuous regional nerve block is recommended.Ramosetron is a newly developed serotonin receptor antagonist with a higher affinity and longer duration of action than that of the previously developed serotonin receptor antagonist such as ondansetron and granisetron. Thus, this prospective blinded randomized study was conducted to document the antiemetic efficacy of multimodal antiemetic protocol to reduce baseline risk, using regional anesthesia, midazolam and propofol, hydration and oxygen supplement and multimodal pain control protocols using the continuous femoral nerve block, PCA and preemptive oral medications and to determine whether Ramosetron prophylaxis would provide additional antiemetic effect in patients after TKA for whom covered by this multimodal antiemetic protocols.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
postoperative nausea and vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ramosetron prophylaxis
Arm Type
Experimental
Arm Description
ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
no antiemetic prophylaxis
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Other Intervention Name(s)
Nasea
Intervention Description
ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days
Primary Outcome Measure Information:
Title
Incidence of Nausea and Vomiting
Description
outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting
Time Frame
within 48 hours after surgery
Secondary Outcome Measure Information:
Title
Incidence of Rescue Antiemetic Administration
Description
outcome assessor assessed the incidence of rescue antiemetic administration
Time Frame
within 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary osteoarthritis, knee
Scheduled for elective total knee arthroplasty
Signed written informed consent
Exclusion Criteria:
Refusing participate
Contraindication to regional anesthesia
Severe impairment of bowel motility
administration of other antiemetics within 24hours before surgery
systemic steroid within 24hours before surgery
history of cardiovascular & respiratory disease
renal & hepatic failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T K Kim, MD,PhD
Organizational Affiliation
Joint Recontruction Center, Seoul National University Bundang hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint Reconstruction Center, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Additional Anti-emetic Effect of Ramosetron Prophylaxis After Total Knee Arthroplasty
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